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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 Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/19/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a part of the blade was completely missing.The target lesion was located at the moderately tortuous and moderately calcified artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention.After completing the procedure, it was noted that a part of the blade was damaged.However, it was further reported that a resistance was noted upon removal and a part of the blade was completely missing.The physician has no idea why it was missing and where the missing part is.The procedure was completed with the original device.No patient complications reported.
 
Event Description
It was reported that a part of the blade was completely missing.The target lesion was located at the moderately tortuous and moderately calcified artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention.After completing the procedure, it was noted that a part of the blade was damaged.However, it was further reported that a resistance was noted upon removal and a part of the blade was completely missing.The physician has no idea why it was missing and where the missing part is.The procedure was completed with the original device.No patient complications reported.
 
Manufacturer Narrative
D4: batch/lot number updated from 0024753734 to unknown as the batch/lot of the returned device 0024368360 would not populate.E1- initial reporter address: (b)(6).Device evaluated by manufacturer: returned product consisted of a wolverine device - 3.00x10.Catheter with batch# 24368360.Based on the potential hazards/failure modes identified, the following attributes were examined: a visual and microscopic examination was performed on the returned device.It was noted that a section of one of the blades, approximately 2mm in length was completely detached from the break point to distal end of the blade.The remaining section of blade was undamaged and fully bonded to the balloon material.The complete pad of the blade remained fully bonded to the balloon material.The detached section of blade was not returned for analysis.The damage identified can potentially be a result of the resistance encountered during use of the device.All other blades were intact and fully bonded to the balloon material.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A microscopic examination identified a balloon pinhole located approximately 5mm distal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.As per wolverine specification the rated burst pressure for this wolverine device is 12 atmospheres.A visual and tactile examination found no kinks or damage to the hypotube of the device.A visual examination identified no damage to the tip of the device.No other issues were observed during analysis.
 
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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 Key10260865
MDR Text Key198513255
Report Number2134265-2020-09080
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 08/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/11/2021
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0024753734
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2020
Date Manufacturer Received07/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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