Threader™ H7493927012120Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729848134), received between Jul 30, 2018 and Aug 30, 2023 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2023Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS PRESENTED WITH CORONARY ARTERY DISEASE AND WAS TO UNDERGO PERCUTANEOUS CORONARY INTERVENTION. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED BUT FAILED TO PASS THE LESION. HOWEVER, DURING THE SECOND INFLATION AT 12 ATMOSPHERES (ATM), THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND ANOTHER 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED, BUT IT ALSO FAILED TO PASS THE LESION AND DURING THIRD INFLATION AT 12 ATM, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND A 1.5X12 NON-BOSTON SCIENTIFIC BALLOON CATHETER WAS PLACED TO TREAT THE LESION. SUBSEQUENTLY, THE PHYSICIAN PROCEEDED TO THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RCA WITH 95% STENOSIS. A 2.25MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING SECOND INFLATION AT 16 ATM, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND DUE TO THE NATURE OF THE PROCEDURE, THE PATIENT WILL BE RETURNING FOR A ROTABLATOR PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17653503 ↗
• MalfunctionAug 30, 2023Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS PRESENTED WITH CORONARY ARTERY DISEASE AND WAS TO UNDERGO PERCUTANEOUS CORONARY INTERVENTION. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED BUT FAILED TO PASS THE LESION. HOWEVER, DURING THE SECOND INFLATION AT 12 ATMOSPHERES (ATM), THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND ANOTHER 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED, BUT IT ALSO FAILED TO PASS THE LESION AND DURING THIRD INFLATION AT 12 ATM, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND A 1.5X12 NON-BOSTON SCIENTIFIC BALLOON CATHETER WAS PLACED TO TREAT THE LESION. SUBSEQUENTLY, THE PHYSICIAN PROCEEDED TO THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RCA WITH 95% STENOSIS. A 2.25MM X 12MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING SECOND INFLATION AT 16 ATM, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND DUE TO THE NATURE OF THE PROCEDURE, THE PATIENT WILL BE RETURNING FOR A ROTABLATOR PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17653501 ↗
• MalfunctionApr 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ANY PROBLEMS BY NORMAL METHOD AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811097 ↗
• MalfunctionNov 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15751416 ↗
• MalfunctionOct 5, 2021Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT CROSSING DIFFICULTY LED TO PROCEDURE CANCELLATION OCCURRED. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE DEVICE WAS NOT ABLE TO CROSS THE LESION. THE PROCEDURE WAS CANCELLED AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576035 ↗
• MalfunctionMar 1, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED, THAT CATHETER ENTRAPMENT OCCURRED. THE 90% STENOSED, TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS. AND MILDLY CALCIFIED FIRST DIAGONAL BRANCH OF THE LEFT ANTERIOR DESCENDING ARTERY. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, AFTER THE SIXTH INFLATION AT 6 ATMOSPHERES FOR 5 SECONDS, THE BALLOON WAS ATTEMPTED TO BE REMOVED, BUT BECAME STUCK WITH THE NON-BOSTON SCIENTIFIC GUIDE WIRE. THE THREADER BALLOON AND THE WIRE WAS THEN REMOVED TOGETHER AS A UNIT. AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON CATHETER. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396163 ↗
• MalfunctionFeb 24, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 99% STENOSED, 12MMX4MM, FOCAL TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED MID RIGHT CORONARY ARTERY. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED FOR DILATION. AFTER IT CROSSED THE LESION, THE DEVICE WAS TAKEN OUT OF THE BODY AND A 6F GUIDE EXTENSION CATHETER WAS ADDED. UPON REINSERTION OF THE DEVICE, THE DELIVERY CATHETER WAS FRACTURED APPROXIMATELY 8 TO 10CM FROM DISTAL TIP WHEN TRAVERSING UP WIRE. THE DEVICE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11373379 ↗
• MalfunctionDec 4, 2020Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23NOV2020 IT WAS REPORTED THAT THE WIRE COULD NOT PASS THROUGH AND WAS CAUGHT IN THE BALLOON. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 1.2MMX12MM THREADER WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE DISTAL TIP OF ROTAWIRE WOULD NOT PASS THROUGH WHEN TRYING TO REMOVE THE BALLOON. IT APPEARS THAT THE WIRE WAS GETTING CAUGHT ON THE DISTAL PART OF THE BALLOON. ANOTHER ROTAWIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10949691 ↗
• MalfunctionSep 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED VIA FACILITY MEDWATCH # (B)(4). THE PATIENT HAD RECENTLY DEMONSTRATED TO HAVE CRITICAL MULTIVESSEL DISEASE WITH LOSS OF ALL GRAFTS INCLUDING LEFT INTERNAL MAMMARY ARTERY (LIMA) TO LEFT ANTERIOR DESCENDING ARTERY (LAD). PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS RECENTLY PERFORMED TO LAD, AND CIRCUMFLEX ARTERY. PCI WAS ALSO PERFORMED TWO DAYS BEFORE TO THE PATIENT'S RIGHT CORONARY ARTERY (RCA). AN 8 FRENCH GUIDE CATHETER, J WIRE, SAMURAI AND 6 FRENCH GUIDEZILLA WAS ADVANCED INTO THE ASCENDING AORTA, AND ENGAGED THE TARGET LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA) WITH 1.25MM AND A 1.2MM X 12MM THREADER BALLOON CATHETER. HOWEVER, DURING INFLATION AT 16-18 ATMOSPHERES, THE BALLOON RUPTURED. THE BALLOON WAS REPLACED WITH A 2.5X15MM COMPLIANT BALLOON, WHICH SUCCESSFULLY DILATED THE LESION. THE GUIDEZILLA WAS UTILIZED TO SUPPORT AND PLACED A 3.5X38 NON BSC STENT AND POST-DILATED WITH A 3.75X20MM NON-COMPLIANT BALLOON. A FOCAL DISSECTION WAS EXPECTED DUE TO DEEP ENGAGEMENT AND GUIDEZILLA UTILIZATION. A 3.5X20MM NON BSC STENT WAS IMPLANTED, AND POST-DILATION WAS PERFORMED AT 20 ATMOSPHERES. ALL DEVICES WERE REMOVED FROM THE PATIENT'S

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10593518 ↗
• MalfunctionSep 9, 2020Burst Container or Vessel

  INCIDENT DESCRIPTION: BALLOON WAS INFLATED IN CALCIFIC LESION TO DILATE RIGHT CORONARY VESSEL, BALLOON BURST AT 16-18ATM DURING INFLATION. INDICATIONS: HIGH-GRADE CRESCENDO ANGINA. MARKEDLY ABNORMAL FUNCTIONAL STUDY. RECENT CARDIAC CATHETERIZATION WITH OCCLUSION OF ALL BYPASS GRAFTS INCLUDING HER LEFT INTERNAL MAMMARY ARTERY (LIMA) TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND GRAFT TO THE CIRCUMFLEX AND RIGHT CORONARY ARTERY. STATUS POST LAD AND CIRCUMFLEX DRUG-ELUTING STENT (DES) AND PERCUTANEOUS CORONARY INTERVENTION (PCI) 2 DAYS PREVIOUSLY. RESIDUAL EXTREMELY HIGH-GRADE ULCERATED STENOSIS IN THE MIDPORTION OF THE RCA. PLAN: THIS PATIENT HAD RECENTLY DEMONSTRATED TO HAVE CRITICAL MULTIVESSEL DISEASE WITH LOSS OF ALL GRAFTS INCLUDING HER LIMA TO THE LAD. SHE IS STATUS POST RECENT DES PCI TO THE LAD AND CIRCUMFLEX SYSTEM AND AS DESCRIBED ABOVE, ATTEMPTED INTERVENTION DAYS PREVIOUSLY TO HER RIGHT CORONARY ARTERY (RCA) AND DESPITE AGGRESSIVE MANIPULATIONS OF THE VESSEL WAS UNABLE TO DELIVER BALLOONS ACROSS THE INDEX LESION. RCA INTERVENTION WAS DEFERRED AT THE TIME, BUT THE VESSEL CLEARLY HAD BEEN AGGRESSIVELY MANIPULATED. NOTES FROM THE PROCEDURE: "AT THIS POINT, AN 8-FRENCH AL1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10507065 ↗
• MalfunctionAug 28, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL CIRCUMFLEX ARTERY. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED BUT WOULD NOT PULL BACK CORRECTLY. THE DEVICE WAS FULLY REMOVED OVER THE WIRE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10465883 ↗
• MalfunctionJul 13, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON CATHETER AND THE WIRE BECAME STUCK. THE MICROCATHETER AND WIRE HAD TO BE REMOVED TOGETHER AND RE-WIRE THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10267143 ↗
• MalfunctionSep 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED AT LESS THAN NOMINAL PRESSURE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8959941 ↗
• MalfunctionJun 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERLY TORTOUS AND SEVERLY CALCIFIED RIGHT CORONARY ARTERY. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE THIRD INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8714657 ↗
• MalfunctionApr 26, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE. THE TARGET LESION WAS LOCATED IN THE CALCIFIED RIGHT CORONARY ARTERY (RCA). A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED TO TREAT THE LESION. PHYSICIAN WAS ABLE TO CROSS THE LESION THAT REQUIRED THE USE OF A 1.5 BURR ROTABLATOR. THE THREADER WAS PLACED ON THE ROTAFLOPPY WIRE AND THE WIRE WAS EXCHANGED OUT FOR A NON-BSC WIRE. THE THREADER WAS THEN USED AGAIN IN THE CASE. IT WAS DIFFICULT TO REMOVE THE THREADER AND IT WAS THOUGHT THE DIFFICULTY WAS DUE TO NEEDING THE OTW THREADER NEEDING TO BE FLUSHED BETTER. THE THREADER WAS THEN USED AGAIN LATER IN THE CASE TO EXCHANGE OUT FOR A NEW NON-BSC WIRE AND WAS FLUSHED WELL WITH HEPARINIZED SALINE BEFORE PLACING ON THE WIRE. IT WENT INTO THE BODY WITH EASE AND THE OLD NON-BSC WIRE WAS REMOVED. A NEW NON-BSC WIRE WAS PLACED THROUGH THE WIRE PORT OF THE OTW THREADER AND UPON TRYING TO REMOVE THE THREADER THE PHYSICIAN WAS UNABLE TO REMOVE THE THREADER. A NEW NON-BSC WIRE WAS PLACED NEXT TO THE NON-BSC WIRE/THREADER COMBO IN THE RCA TO RE-WIRE THE LESION IN RCA AND THE NON-BSC WIRE/THREADER COMBO WAS REMOVED. THE SINGLE, NEW NON-BSC WIRE WAS LEFT IN PLACE. THE PATIENT WAS UNHAR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8556647 ↗
• MalfunctionSep 20, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 4 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED BY SIMPLY PULLED OUT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. RETURNED PRODUCT CONSISTED OF A THREADER BALLOON CATHETER. THE OUTER SHAFT, INNER SHAFT, BALLOON AND TIP WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION DID NOT REVEAL ANY DAMAGES. MICROSCOPIC EXAMINATION REVEALED THAT THE TIP IS DAMAGED AND THE BALLOON IS LOOSELY FOLDED. THERE IS A PINHOLE 1MM FROM THE MARKER BAND. THERE IS NO INDICATION THE DEVICE WAS INFLATED OVER RATED BURST PRESSURE (RBP).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7895092 ↗
• MalfunctionJul 30, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. A 1.2MM X 12MM THREADER BALLOON CATHETER WAS SELECTED FOR A PROCEDURE IN THE CORONARY ARTERY. AFTER CROSSING THE LESION, DILATATION WAS PERFORMED APPROXIMATELY THREE TIMES. HOWEVER, THE PRESSURE BECAME UNABLE TO INCREASE PART WAY THROUGH AND THE BALLOON RUPTURED. THE DEVICE WAS ABLE TO BE REMOVED FROM THE PATIENT WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7730819 ↗