Interlock™-35 M001363760Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729793052), received between Nov 8, 2018 and May 20, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT A COIL PIERCED THE CATHETER. DURING AN INTERNAL ILIAC BONE EMBOLIZATION PROCEDURE, AN 8 MM X 20 CM INTERLOCK-35 COIL WAS SELECTED FOR USE. THE ANATOMY WAS REPORTED AS MODERATELY TORTUOUS. AN INTERMITTENT FLUSH SETUP WAS UTILIZED, AND A FLUSH WAS PERFORMED PRIOR TO INSERTION OF THE COIL. THE COIL WAS USED IN COMBINATION WITH A NON-BOSTON SCIENTIFIC ANGIOGRAPHIC CATHETER WITH AN INTERNAL DIAMETER OF 0.038 INCH. DURING THE PROCEDURE, THE LOCKING ARM PORTION OF THE INTERLOCK DEVICE DID NOT FOLLOW THE CURVE OF THE CATHETER, RESULTING IN PIERCING THE CATHETER AND PROTRUSION INTO THE BLOOD VESSEL. THERE WAS NO VASCULAR DAMAGE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25236186 ↗
• MalfunctionDec 4, 2025Premature Activation; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Premature Activation; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08NOV2025. IT WAS REPORTED THAT DEVICE UNABLE TO ADVANCE AND PREMATURE DEPLOYMENT OCCURRED. AN 8MM X 20CM .035 INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL COULD NOT BE DELIVERED OUT. AFTER RE-ADJUSTING AND REPLACING THE ANGIOGRAPHIC CATHETER, THE COIL STILL COULD NOT BE DELIVERED AND DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A MAIN COL DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717479 ↗
• MalfunctionJul 2, 2025Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06-JUN-2025. IT WAS REPORTED THAT COIL DIFFICULT TO INSERT OCCURRED. A 8MM X 20CM .035 INTERLOCK CUBE WAS USED FOR TREATMENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK IN THE CATHETER HUB PART. THE COIL WAS REMOVED AS IT WAS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A MAIL COIL DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22388056 ↗
• MalfunctionAug 3, 2023Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THE COIL COULD NOT ADVANCE THE CATHETER. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 8MM X 20CM INTERLOCK .035 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSIVELY DEPLOYED TWO 35 SYSTEM COILS OF 12MMX40CM AND 10X40, AND THEN CONTINUED TO DEPLOY A 35 SYSTEM COIL OF 8X20. HOWEVER, THIS COIL WAS STUCK IN THE POSTERIOR SECTION OF THE ANGIOGRAPHY CATHETER. THE PHYSICIAN COULD NOT ADVANCE IT AFTER SEVERAL ATTEMPTS. THEN, THE COIL WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL DETACHED AT THE ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455012 ↗
• MalfunctionApr 7, 2023Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16MAR2023. IT WAS REPORTED THAT THE COIL WAS DELIVERED WITH TOO MUCH RESISTANCE AND UNSCREWED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ILIAC ARTERY OF THE ABDOMINAL AORTA. AN 8MMX20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY, IT WAS NOTED THAT THE COIL WAS DELIVERED INTO THE DIREXION CATHETER WITH TOO MUCH RESISTANCE. SUBSEQUENTLY, THE COIL UNSCREWED AFTER PULLBACK AND WAS THEN UNUSABLE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE. HOWEVER, ANALYSIS REVEALED THAT THE MAIN COIL DETACHED IN THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702582 ↗
• MalfunctionFeb 13, 2023Premature Activation; Premature Activation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18JAN2023. IT WAS REPORTED THAT THE COIL GOT DETACHED INSIDE THE MICROCATHETER. THE TARGET LESION WAS LOCATED IN THE GASTROESOPHAGEAL CARICES. A 8MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, WHILE RECAPTURING FOR REPOSITIONING OF THE COIL, IT WAS NOTED THAT THE COIL GOT DETACHED INSIDE THE MICROCATHETER. THE COIL WAS WITHDRAWN AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368477 ↗
• MalfunctionDec 2, 2022Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  IT WAS REPORTED THAT THE COIL WAS BEING PROTRUDED FROM THE TIP OF THE CATHETER WHEN THE COIL WAS REMOVED. THE NON STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. AN 8MM X 20CM INTERLOCK -35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE LEADS TO EARLY DETACHMENT IN THE IMAGING CATHETER. FURTHERMORE, WHEN THE COIL WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE COIL PROTRUDED FROM THE TIP OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15904584 ↗
• MalfunctionAug 12, 2022Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15JUL2022. IT WAS REPORTED THAT THE COIL COULD NOT BE FULLY ADVANCED AFTER SEVERAL ATTEMPTS. THE TARGET LOCATION WAS LOCATED IN THE LIVER. AN 8MMX20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE FULLY ADVANCED AFTER SEVERAL ATTEMPTS. THE DEVICE WAS SIMPLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15220988 ↗
• MalfunctionJun 30, 2022Entrapment of Device; Difficult to Remove; Device-Device Incompatibility; Entrapment of Device; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT THE COIL HAS COME OUT OF THE CATHETER. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED INTERNAL ILIAC ARTERY. A 8MM X 20CM .035 INTERLOCK CUBE EMBOLICS WAS SELECTED FOR USE. DURING DELIVERY OF THE PRODUCT, A GUTTER WAS CREATED BY BREAKING THROUGH THE WALL OF THE CATHETER INSTEAD OF THE TIP AND THE COIL HAS COME OUT OF THE CATHETER. THE ENTIRE CATHETER WAS REMOVED, HOWEVER, TWO-THIRDS OF THE COIL PROTRUDED FROM THE TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880660 ↗
• MalfunctionApr 27, 2022Premature Activation; Stretched; Failure to Advance; Premature Activation; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE COIL WAS STRETCHED AND GOT DETACHED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 8MMX20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, A 20MMX40MM INTERLOCK-35 WAS SELECTED TO TREAT THE PATIENT WHO HAS MAXIMUM TUMOR DIAMETER OF 1.6CM. HOWEVER, WHEN THE COIL WAS DEPLOYED, IT WAS FOUND OUT THAT IT WAS NOT SO TIGHT. SO, A 8MMX20CM COIL WAS USED AND THERE WAS RESISTANCE FELT, THEREFORE THE COIL WAS WITHDRAWN AND RE-DEPLOYED. CONSEQUENTLY, WHEN THE COIL WAS WITHDRAWN AGAIN, IT WAS NOTED THAT THE COIL WAS STRETCHED AND GOT DETACHED FROM THE DELIVERY WIRE. THE PHYSICIAN CONCLUDED THAT THE SIZE OF THE COIL WAS TOO LARGE TO DEPLOY, AN STC18 MICROCATHETER WAS USED TO EXTEND TO THE POSITION OF THE TUMOR. THE COIL AND CATHETER WAS WITHDRAWN AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED AND THERE WERE MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14229302 ↗
• MalfunctionApr 13, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP DURING REMOVAL. THE NON STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON CALCIFIED INTERNAL ILIAC ARTERY. A 8MMX20CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE DISTAL PART OF THE CATHETER. FURTHERMORE, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE COIL PROTRUDED FROM THE TIP OF THE MICROCATHETER. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657045 ↗
• MalfunctionAug 24, 2020Entrapment of Device; Premature Activation; Stretched; Entrapment of Device; Premature Activation; Stretched

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP UPON REMOVAL. THE TARGET LESION WAS LOCATED AT RENAL ARTERY. AN 8MM X 40CM AND 8MM X 20CM INTERLOCK-35 COIL WERE SELECTED FOR USE IN A PERIPHERAL EMBOLIZATION OF HEMORRHAGE. THE FIRST 8MM X 40CM COIL WAS INTRODUCED AND WORKED FINE. DURING THE ADVANCEMENT AND WITHDRAWAL OF THE CATHETER WITH THE COIL, THE PHYSICIAN FELT RESISTANCE WHEN THE SECOND INTERLOCK 35 8MM X 20CM WAS INTRODUCED. INTERMITTENT FLUSHING WAS PERFORMED AND THE COIL WAS ADVANCED INTO THE CATHETER. THE COIL WAS NOT MOVING OR ALTERING ITS POSITION AFTER ABOUT TWO THIRDS INTO THE PATIENT. THE INTERLOCKING ARM OF THE COIL DETACHED/UNLOCKED FROM THE INTERLOCKING ARM OF THE PUSHER WIRE. THE COIL WAS UNABLE TO BE PUSHED WITH ANOTHER WIRE. THE DEVICE WAS REMOVED AND PULLED BACK ALONG WITH THE CATHETER FROM THE PATIENT THOUGH ITS PROXIMAL PART WAS UNWOUND AND VISUALLY STRETCHED. THE DEPLOYED PORTION OF THE COIL PROTRUDED FROM THE CATHETER'S TIP UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER 6MM X 20CM 2D INTERLOCK 35 COIL SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10445171 ↗
• MalfunctionJul 2, 2020Entrapment of Device; Entrapment of Device

  IT WAS NOTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP. AN 8MMX20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COIL STUCK IN THE DISTAL PART OF THE IMAGER II CATHETER. SUBSEQUENTLY, THE COIL WAS REMOVED TOGETHER WITH THE CATHETER AND WAS NOTED PROTRUDING FROM THE CATHETER'S TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224530 ↗
• MalfunctionJun 19, 2020Activation, Positioning or Separation Problem

  THERE WERE ISSUES WITH TWO COILS: #1 WOULD NOT GO INTO CATHETER FOR DEPLOYMENT (LOT# 23071590). #2 CATHETER DETACHED IN CATHETER (LOT# 24574482). THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10173412 ↗
• MalfunctionJun 4, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED IN THE CATHETER'S TIP DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT INTERNAL ILIAC ARTERY. A 8MMX20CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE DEVICE WAS DELIVERED TO THE TARGET LESION, IT WAS NOTED THAT THE SHEATH GOT KINKED AND THE COIL DETACHED PREMATURELY INSIDE THE MICROCATHETER. FURTHERMORE, WHEN THE COIL WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE COIL PROTRUDED FROM THE TIP OF THE 5FR IMAGER MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10120685 ↗
• MalfunctionDec 2, 2019Entrapment of Device; Difficult to Insert; Entrapment of Device; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19NOV2019. IT WAS REPORTED THAT THE COIL WAS STUCK INSIDE THE CATHETER. AN 8MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE COIL ONLY REACHED THE DISTAL PART OF THE CATHETER AND COULD NOT ADVANCE TO THE PROPER POSITION. CONSEQUENTLY, THE COIL WAS PULLED BACK INTO THE CATHETER. DURING THE SECOND ATTEMPT TO ADVANCE THE COIL, THE COIL BECAME STUCK INSIDE THE CATHETER. THE COIL WAS REMOVED WITHIN THE CATHETER ALL TOGETHER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9395205 ↗
• MalfunctionJan 29, 2019Break; Separation Failure; Break; Separation Failure

  IT WAS REPORTED THAT THE GUIDEWIRE BROKE OFF. A 8MM X 20CM INTERLOCK CUBE WAS SELECTED FOR EMBOLIZATION OF THE TARGET LESION. THE COIL WAS INSERTED THROUGH A 4F ANGIOGRAPHY CATHETER AND THERE WAS DIFFICULTY TO DETACH THE PUSHER WIRE FROM THE COIL AFTER THE COIL WAS DEPLOYED WITHIN THE LESION. SUBSEQUENTLY, THE PUSHER WIRE BROKE, THE PHYSICIAN WAS ABLE TO WITHDRAW THE PUSHER WIRE THROUGH THE CATHETER. NO DEVICE FRAGMENTS WERE LEFT WITHIN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8285556 ↗
• MalfunctionJan 24, 2019Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. A 8MM/20CM 0.35 INTERLOCK-35 WAS SELECTED FOR EMBOLIZATION OF THE RENAL ARTERIAL ANEURYSM. DURING THE PROCEDURE, THE PUSHER WIRE ARM WAS FOUND TO BE BROKEN INSIDE THE CATHETER. THE DEVICE WAS REMOVED WITHIN THE CATHETER ALL TOGETHER AND IT WAS CONFIRMED THAT THERE WAS NO FRAGMENTS OF THE DEVICE THAT WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND PATIENT IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8273704 ↗
• MalfunctionDec 17, 2018Break; Break

  IT WAS REPORTED THAT A PUSHER WIRE BREAK OCCURRED. A .035 INTERLOCK CUBE 8MM X 20CM WAS SELECTED FOR A ILIAC ARTERY EMBOLIZATION PROCEDURE. THE COIL WAS ABLE TO ADVANCE THROUGH THE 4F CATHETER BUT THE COIL FAILED TO DEPLOY. THE PUSHER WIRE BROKE AS A RESULT OF FORCE USED BY THE PHYSICIAN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8170496 ↗
• MalfunctionNov 8, 2018Premature Activation; Material Protrusion/Extrusion; Physical Resistance/Sticking; Premature Activation; Material Protrusion/Extrusion; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE COIL WAS PROTRUDING FROM THE TIP OF THE CATHETER UPON REMOVAL FROM THE PATIENT. A 8MM/20CM 0.35 INTERLOCK WAS SELECTED FOR THE ABDOMINAL AORTIC ANEURYSM REPAIR PROCEDURE. THE TARGET LESION WAS MODERATELY CALCIFIED. DURING THE PROCEDURE, THE COIL WAS ABLE TO ADVANCE TO THE DISTAL PART OF THE IMAGER II CATHETER, BUT IT THEN BECAME STUCK AFTER PROTRUDING FROM THE TIP OF THE CATHETER, AND CURLED 2 OR 3 TIMES. THEN THE INTERLOCKING ARM OF THE COIL UNLOCKED FROM THE INTERLOCKING ARM OF THE PUSHER WIRE WHILE MOVING. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER AS ONE UNIT. NO DEVICE FRAGMENTS WERE LEFT INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETE WITH THIS DEVICE. NO COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8052766 ↗