NanoCross™ Elite AB14W060200150 (UDI 00763000110529)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000110529), received between Oct 30, 2019 and Jul 10, 2024 — classified as 7 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K141118); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2024Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON DURING TREATMENT OF THE PATIENTS SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE OR POST DILATED. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. A BALLOON BURST DURING PROCEDURE ON THE FIRST INFLATION WAS REPORTED. THE BALLOON WAS INSIDE THE PATIENT WHEN THE BURST OCCURRED. THE PRESSURE AT WHICH THE BURST OCCURRED IS UNKNOWN. THE BALLOON DID NOT DETACH DURING THE EVENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A REPLACEMENT MEDTRONIC DEVICE WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710951 ↗
• MalfunctionApr 24, 2024Leak/Splash; Material Twisted/Bent; Leak/Splash; Material Twisted/Bent

  A PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON DURING TREATMENT OF A 200MM LESION IN PATIENTS SUPERFICIAL FEMORAL ARTERY (SFA). ARTERY DIAMETER REPORTED AS 6MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS POST-DILATED. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 50/50 CONTRAST FLUID WAS USED. THE BALLOON WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. A BALLOON TWIST WAS REPORTED. A DOG-BONE/TWIST WAS NOT VISIBLE WITHIN THE BALLOON IN THE VESSEL. A REWRAP TOOL WAS NOT USED. A HUB/LEUR LEAK DURING PROCEDURE WAS ALSO REPORTED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A 6MM X 20MM FORTREX BALLOON WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172521 ↗
• MalfunctionMar 1, 2024Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON CATHETER WITH A SPIDER FX EMBOLIC PROTECTION DEVICE/GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN PATIENTS RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL CALCIFICATION WAS REPORTED. LESION EXHIBITED 80% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. THE VESSEL WAS PRE-DILATED. THE VESSEL WAS NOT POST-DILATED. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 50/50 CONTRAST INFLATION FLUID WAS USED. THE DEVICE WAS PASSED THROUGH A NON-MEDTRONIC STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. A BALLOON BURST AT 14ATM DURING PROCEDURE WAS REPORTED. 3 PRIOR INFLATIONS WERE APPLIED TO THE DEVICE PRIOR TO OCCURRING. THE BALLOON DETACHED DURING THE EVENT. NOT ALL PARTS OF THE BALLOON WERE REMOVED. THE DETACHED PORTION OF DEVICE WAS LEFT IN THE PATIENT WITH NO INTERVENTION REQUIRED. PROCEDURE WAS ABORTED. NO PATIENT INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18815319 ↗
• MalfunctionSep 6, 2023Burst Container or Vessel; Difficult to Advance; Burst Container or Vessel; Difficult to Advance

  A NANOCROSS ELITE WAS BEING USED FOR TREATMENT OF A CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION IN THE DISTAL REGION OF THE SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. THERE WAS MILD TORTUOSITY AND SEVERE CALCIFICATION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. IT WAS REPORTED THE BALLOON BURST LONGITUDINALLY AT 6ATM DURING THE SECOND INFLATION. ALL FRAGMENTS WERE RETRIEVED. THE DEVICE HAD NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS MET DURING ADVANCEMENT. A 6X120 PTA WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690624 ↗
• MalfunctionAug 21, 2023Leak/Splash; Leak/Splash

  A PHYSICIAN WAS USING A NANOCROSS ELITE DURING THE TREATMENT OF A CALCIFIED LESION WITH 30% STENOSIS IN THE PROXIMAL REGION OF THE SUPERFICIAL FEMORAL ARTERY. THERE WAS MILD TORTUOSITY AND SEVERE CALCIFICATION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED DURING THE 5TH INFLATION AT 10 ATM A PINHOLE LEAK OCCURRED. A SECOND NANOCROSS BALLOON ALSO BURST AT 8 ATM ON THE 1ST INFLATION, BUT WAS ABLE TO KEEP THE BALLOON UP FOR 1 MINUTE OF ANGIOPLASTY, THE PHYSICIAN DECIDED NOT TO TRY ANOTHER BALLOON. ALL FRAGMENTS WERE RETRIEVED. UPON REMOVING THE BALLOON FROM THE SHEATH AND PATIENT THE PROVIDER AND TECH CONFIRMED ON THE BACK TABLE THAT ALL FRAGMENTS OF THE BALLOON REMAINED INTACT AND NO FRAGMENTS WERE LEFT IN PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17582149 ↗
• InjuryJan 17, 2023Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  A PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS BALLOON DURING PROCEDURE TO TREAT THE PROXIMAL SUPERFICIAL FEMORAL ARTERY OF A PATIENT. THE LESION WAS SEVERELY CALCIFIED AND LITTLE TORTUOUS WITH 99% STENOSIS. ARTERY DIAMETER 7MM AND LESION LENGTH 250MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. DEVICE PREPPED PER THE IFU, WITH NO ISSUES IDENTIFIED. RESISTANCE WAS FELT DURING ADVANCEMENT. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. IT IS REPORTED THERE WAS A LONGITUDINAL BALLOON BURST AT 14ATM. AFTER A SERIES OF PRE-DILATATIONS USING A 3.5X100 AND A 5X150 NANOCROSS BALLOONS, THE PHYSICIAN COULD NOT ADVANCE A NON-MEDTRONIC BALLOON TO TREAT A SEVERELY CALCIFIED NAPKIN RING LESION IN THE MID SFA. THE 6X200MM NANOCROSS BALLOON WAS ABLE TO CROSS AND THE PHYSICIAN TOOK IT TO BURST TO CRACK THE LESION OPEN. THE BALLOON RUPTURED AT 14ATM BUT REMAINED ON THE CATHETER. THE PHYSICIAN HAD A HARD TIME DEFLATING THE RUPTURED BALLOON. EXCESSIVE FORCE WAS USED DURING WITHDRAWAL. DURING WITHDRAWAL THROUGH THE MOUTH OF THE SHEATH, THE BALLOON CAME OFF THE BALLOON CATHETER COMPL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16182902 ↗
• MalfunctionAug 16, 2022Material Twisted/Bent; Material Twisted/Bent

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS ELITE PTA BALLOON ALONG WITH A NON-MEDTRONIC 6FR SHEATH DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS NONE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5.5MM AND 250MM RESPECTIVELY. NO EMBOLIC PROTECTION WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED WHEN REMOVING FROM HOOP/TRAY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT BALLOON TWIST OCCURRED WITH NO REWRAP ISSUE NOTED. MOVED BALLOON TO ENSURE ALL OF THE VESSEL WAS BALLOONED. ONCE INFLATIONS WERE COMPLETE, BALLOON WAS REMOVED AND INFLATED ON BACK TABLE. AT THAT TIME THE BALLOON INFLATED COMPLETELY. WE WATCHED IT UNWRAP AND INFLATE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15231130 ↗
• MalfunctionAug 5, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE NANOCROSS PTA BALLOON DURING PROCEDURE. INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THEE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. A HEP SALINE/CONTRAST MIXTURE WAS USED FOR BALLOON INFLATION. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. IT WAS REPORTED THAT BALLOON BURST, LEAK OR CATHETER LEAK OCCURRED DURING FIRST INFLATION. BALLOON WAS ONLY INFLATED FOR ABOUT 5 SECONDS. THE BALLOON BURST WAS REPORTED AT 8ATM. THE BALLOON DID NOT FRAGMENT. PHYSICIAN USED AN EVERCROSS WITH NO ISSUES AND CONTINUED WITH PROCEDURE. NO VESSEL INJURY NOTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15174544 ↗
• InjuryMar 23, 2022Deflation Problem; Deflation Problem

  PHYSICIAN WAS ATTEMPTING TO USE NANOCROSS ELITE PTA BALLOON CATHETER DURING PROCEDURE TO TREAT A NONE CALCIFIED FIBROUS LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 90% STENOSIS. THE VESSEL WAS LITTLE TORTUOUS. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED. THE DEVICE WAS SLOW TO DEFLATE AT THE LESION SITE WITH A DEFLATION TIME OF 8 MINUTES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. A 60CC SYRINGE WAS USED TO DEFLATE THE BALLOON. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13857323 ↗
• InjuryMar 23, 2022Deflation Problem; Deflation Problem

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS ELITE PTA BALLOON DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 85% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. A NON-MEDTRONIC DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED. THE DEVICE WAS SLOW TO DEFLATE AT THE LESION SITE WITH A DEFLATION TIME OF 3 MINUTES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. A 60CC SYRINGE WAS USED TO DEFLATE THE BALLOON. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13856393 ↗
• InjuryDec 16, 2021Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE THE NANOCROSS ELITE PTA BALLOON CATHETER DURING PROCEDURE TO TREAT LITTLE CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL HAD NO TORTUOSITY. THE ARTERY DIAMETER WAS 5.5 MM. A NON MEDTRONIC 6FR SHEATH AND 0.014'' GUIDEWIRE WERE USED. THE DEVICE WAS INFLATED WITH A NON MEDTRONIC INFLATION DEVICE. SALINE/CONTRAST INFLATION FLUID WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED WITH NO ISSUES. IT WAS REPORTED THAT THERE WAS A BALLOON BURST/LEAK AT THE LUER/HUB DURING THE FIRST BALLOON INFLATION AT 4-5 ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE DEVICE DETACHED/CRACKED/FRACTURED AT BALLOON DURING REMOVAL FROM PATIENT AFTER INFLATIONS. A NON MEDTRONIC SNARE WAS USED TO REMOVE THE DETACHED PORTION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. AFTER THE BALLOON WAS REMOVED WITH SNARE THE PROCEDURE WAS COMPLETED WITH COMPLETION ANGIOGRAMS TO CONFIRM SATISFACTORY RESULTS. NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13018574 ↗
• InjuryOct 20, 2021Burst Container or Vessel; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE THE NANOCROSS ELITE PTA BALLOON DURING PROCEDURE TO TREAT SEVERELY CALCIFIED LESION IN THE DISTAL, MID AND PROXIMAL LOCATION OF THE RIGHT COMMON ILIAC ARTERY AND SUPERFICIAL FEMORAL ARTERY. THE VESSEL EXHIBITED 60-80% DIFFUSED STENOSIS AND HAD MODERATE TORTUOSITY. THE ARTERY DIAMETER WAS 7.0MM AND LESION LENGTH WAS 200MM. A 6FR SHEATH WAS USED. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. THE BALLOON WAS INFLATED WITH A NON MEDTRONIC(BOSTON) INFLATION DEVICE. IT WAS REPORTED THAT THERE WAS A BALLOON BURST/LEAK DURING BALLOON INFLATION AT 12 ATM ON THE 3RD INFLATION. NOT ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE BALLOON ACCORDIONED/BUNCHED UP UPON RETRIEVAL AT WHICH POINT IT DETACHED FROM THE CATHETER. PHYSICIAN WAS UNABLE TO RETRIEVE THE BALLOON SO DECISION WAS MADE TO TACK THE BALLOON AGAINST THE WALL OF THE COMMON LEFT ILIAC AND THE RIGHT EXTERNAL ILIAC. THE BALLOON ACCORDIONED ON ITSELF I

  Patient problems: Insufficient Information

  MAUDE report 12665075 ↗
• InjuryMay 5, 2021Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON WITH A 6FR NON-MEDTRONIC SHEATH AND 0.014 GUIDEWIRE DURING TREATMENT OF A 330MM FIBROUS CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND COMMON ILIAC ARTERY. MODERATE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. ARTERY DIAMETER REPORTED AS 6MM. HEP SALINE AND CONTRACT MIXTURE WERE USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE TO THE PRODUCT PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS PERFORMED WITH A 3MM NANOCROSS AND ATHERECTOMY WAS PERFORMED. FOLLOWING THIS THE NANOCROSS ELITE BALLOON WAS INSERTED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. THE DISTAL SEGMENT WAS BALLOONED FIRST FOLLOWED BY 2 MORE INFLATIONS PROXIMAL TO THE FIRST INFLATION. THE FINAL INFLATION USING THE BALLOON INCLUDED THE OSTIAL SFA. A BALLOON BURST IS REPORTED TO HAVE OCCURRED ON 4TH FINAL INFLATION. JUST AFTER THE TAKEOFF OF THE SFA, THE BALLOON MET A RESISTANT SEGMENT WHICH IS WHERE IT IS SUSPECTED THE BURST OCCURRED. THE BURS

  Patient problems: Obstruction/Occlusion; Unspecified Tissue Injury

  MAUDE report 11775936 ↗
• MalfunctionFeb 13, 2020Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  PHYSICIAN INTENDED TO USE A NANOCROSS ELITE DEVICE WITH A NON-MEDTRONIC 6FR SHEATH AND 0.014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A PLAQUE LESION IN THE PATIENT¿S MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. EMBOLIC PROTECTION WAS NOT USED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. CONTRAST WAS USED FOR INFLATION. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED THAT THERE WAS DIFFICULTY ENCOUNTERED WHEN REMOVING THE BALLOON ON THE WIRE AND FORCE WAS REQUIRED. ALL DEVICES REMOVED IN TANDEM. IT IS REPORTED THAT ON REMOVAL, IT APPEARED A PIECE OF THE BALLOON MATERIAL WAS MISSING. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9705673 ↗
• InjuryOct 30, 2019Burst Container or Vessel; Fracture; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Fracture; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON TO TREAT A SEVERELY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY PRESENTING CTO (CHRONIC TOTAL OCCLUSION 100%). THE VESSEL WAS MODERATELY TORTUOUS. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING AND THERE WAS NO ISSUE REMOVING THE DEVICE FROM THE HOOP TRAY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. A NON-MEDTRONIC INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. EMBOLIC PROTECTION WAS NOT USED. THE BALLOON WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE WHEN ADVANCING WITH THE DEVICE. IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED DURING BALLOON INFLATION AT 6 ATM. FOUR PREVIOUS INFLATION'S WERE CARRIED OUT PRIOR TO THE ISSUE OCCURRING. THE PHYSICIAN EXPERIENCED REMOVAL DIFFICULTIES AND IT WAS REPORTED THAT THE CATHETER BROKE/FRACTURED DURING REMOVAL FROM THE PATIENT. A NON-MEDTRONIC BIOPSY FORCEPS WAS USED TO REMOVE THE DEVICE FRAGMENTS FROM THE PATIENT. AFTER THE RUPTURED NANOCROSS WAS REMOVED, THEN PULLED SHEATH AND CLOSED WITH A NON-MEDTRONIC 6 FR VASCULAR CLOSURE DEVICE.

  Patient problems: Injury

  MAUDE report 9254976 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141118. One submission often covers many models, so check the product and lot details in each record.

• Z-0904-2025 · Dec 10, 2024 · Open, Classified
  Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090,