Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
Model Number 3851
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Event Date 12/08/2020
Event Type  Injury  
Manufacturer Narrative
Initial reporter address 1: (b)(6).
 
Event Description
It was reported that the blade separated, stuck in lesion and stenting was done.The 90% stenosed target lesion was located in the left moderately tortuous and moderately calcified left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During procedure, the balloon was expanded for several times after passing through the lesion since it was difficult to pass through.However, the device got stuck in the lesion and was difficult to remove after deflation.The device was then removed by passing another guidewire through the lesion and expanding it with a small-diameter balloon.Upon checking it outside patient's body, it was confirmed that a part of the blade that should have been attached originally had fallen off/dislodged as one blade was longer on the proximal part at the flex point part.A high-intensity shadow image was then confirmed on the lesion by optical frequency domain imaging.Judging that the blade stuck/bitten into the lesion area, a stent was placed and the procedure was ended with a different device.No further complications were reported and there was no adverse effect observed to the patients health.
 
Event Description
It was reported that the blade separated, stuck in lesion and stenting was done.The 90% stenosed target lesion was located in the left moderately tortuous and moderately calcified left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During procedure, the balloon was expanded for several times after passing through the lesion since it was difficult to pass through.However, the device got stuck in the lesion and was difficult to remove after deflation.The device was then removed by passing another guidewire through the lesion and expanding it with a small-diameter balloon.Upon checking it outside patient's body, it was confirmed that a part of the blade that should have been attached originally had fallen off/dislodged as one blade was longer on the proximal part at the flex point part.A high-intensity shadow image was then confirmed on the lesion by optical frequency domain imaging.Judging that the blade stuck/bitten into the lesion area, a stent was placed and the procedure was ended with a different device.No further complications were reported and there was no adverse effect observed to the patients health.It was further reported that the separated part of the blade was left inside the patient's body and that a stent was deployed as an intervention on the lesion area where the blade was stuck.
 
Manufacturer Narrative
E1: initial reporter address 1 - (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.3 blades were present on the balloon surface however the following blade damage was noted: blade 1- no issues noted with this blade.Blade 2- blade segment was found to be lifted from its pad at the flex point.Pad remained secured to the balloon surface.Blade 03- blade segment missing from pad- from the proximal end of the pad to the flex point.Pad remained secure to the balloon surface.A visual and tactile examination found no issues with the hypotube of this device.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.
 
Manufacturer Narrative
E1: initial reporter address 1 (b)(6).
 
Event Description
It was reported that the blade separated, stuck in lesion and stenting was done the 90% stenosed target lesion was located in the left moderately tortuous and moderately calcified left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During procedure, the balloon was expanded for several times after passing through the lesion since it was difficult to pass through.However, the device got stuck in the lesion and was difficult to remove after deflation.The device was then removed by passing another guidewire through the lesion and expanding it with a small-diameter balloon.Upon checking it outside patient's body, it was confirmed that a part of the blade that should have been attached originally had fallen off/dislodged as one blade was longer on the proximal part at the flex point part.A high-intensity shadow image was then confirmed on the lesion by optical frequency domain imaging.Judging that the blade stuck/bitten into the lesion area, a stent was placed and the procedure was ended with a different device.No further complications were reported and there was no adverse effect observed to the patients health.It was further reported that the separated part of the blade was left inside the patient's body and that a stent was deployed as an intervention on the lesion area where the blade was stuck.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
WOLVERINE CORONARY CUTTING BALLOON MONORAIL
Type of Device
CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11022751
MDR Text Key221866817
Report Number2134265-2020-17948
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 02/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/12/2022
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0026172505
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Date Manufacturer Received01/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-