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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
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BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
Model Number 3851
Device Problem Material Rupture (1546)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/25/2020
Event Type  malfunction  
Manufacturer Narrative
Initial reporter city: (b)(6).
 
Event Description
It was reported that a balloon rupture occurred.The 95% stenosed target lesion was located in the non tortuous and severely calcified in-stent restenosis (isr) in the left circumflex artery.During procedure, a 10mmx2.50mm wolverine coronary cutting balloon was selected for use.Before using this device, when the situation inside the isr was observed by oct, a protruding part of calcification was confirmed.Then, the front and back of the protruding part were expanded with the wolverine balloon.However, at third inflation, it was noted that the balloon ruptured at 12atm.The device was removed from the patient's body without any problem and the procedure was completed with a different device.No patient complications were reported and patient's condition was good post procedure.
 
Manufacturer Narrative
E1 - initial reporter city: (b)(6).Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood and solidified media were also present inside the balloon material.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of solidified media.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the media before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device, subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located at approximately 4mm proximal from the distal marker band.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres as per wolverine label specification.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination found no issues with the hypotube of this device.The markerbands and tip and of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.
 
Event Description
It was reported that a balloon rupture occurred.The 95% stenosed target lesion was located in the non tortuous and severely calcified in-stent restenosis (isr) in the left circumflex artery.During procedure, a 10mmx2.50mm wolverine coronary cutting balloon was selected for use.Before using this device, when the situation inside the isr was observed by oct, a protruding part of calcification was confirmed.Then, the front and back of the protruding part were expanded with the wolverine balloon.However, at third inflation, it was noted that the balloon ruptured at 12atm.The device was removed from the patient's body without any problem and the procedure was completed with a different device.No patient complications were reported and patient's condition was good post procedure.
 
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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 Key11083431
MDR Text Key224049150
Report Number2134265-2020-18513
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
Report Date 02/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/22/2022
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0026057164
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2021
Date Manufacturer Received02/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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