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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 Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem Discomfort (2330)
Event Date 01/23/2021
Event Type  Injury  
Event Description
It was reported that failure to deflate a balloon, difficulty removing the device, patient discomfort, and additional interventional occurred.A percutaneous coronary intervention (pci) was performed on a patient with a severely calcified stenosis in the coronary artery.A 10mm x 3.00mm wolverine cutting balloon was advanced to dilate the target lesion, but could not be deflated fully in the proximal end.The blade got stuck in the calcium in the lesion, the blade did not detach nor did it partially lift, and the device was difficult to remove from the lesion.It was only possible to move the device distally.The wolverine could not deflate correctly in the proximal end of the balloon and could not be retrieved.It was noted that it appeared like arrow with proximal end was not deflated.Additional balloons were used in parallel to crimp the wolverine to be able to withdraw the wolverine device.The balloon was deflated several times prior to a removal attempt.A wire and balloon was placed next to the wolverine and inflated several times to compress the wolverine and then the wolverine could be retrieved.The balloon was noted to be deflated enough to be removed from the patient.The patient experienced discomfort while withdrawing the device.The procedure was successfully completed with another of the same device.No additional patient complications resulted in relation to this event and the patient was reported to be fully recovered.
 
Event Description
It was reported that failure to deflate a balloon, difficulty removing the device, patient discomfort, and additional interventional occurred.A percutaneous coronary intervention (pci) was performed on a patient with a severely calcified stenosis in the coronary artery.A 10mm x 3.00mm wolverine cutting balloon was advanced to dilate the target lesion, but could not be deflated fully in the proximal end.The blade got stuck in the calcium in the lesion, the blade did not detach nor did it partially lift, and the device was difficult to remove from the lesion.It was only possible to move the device distally.The wolverine could not deflate correctly in the proximal end of the balloon and could not be retrieved.It was noted that it appeared like arrow with proximal end was not deflated.Additional balloons were used in parallel to crimp the wolverine to be able to withdraw the wolverine device.The balloon was deflated several times prior to a removal attempt.A wire and balloon was placed next to the wolverine and inflated several times to compress the wolverine and then the wolverine could be retrieved.The balloon was noted to be deflated enough to be removed from the patient.The patient experienced discomfort while withdrawing the device.The procedure was successfully completed with another of the same device.No additional patient complications resulted in relation to this event and the patient was reported to be fully recovered.It was further reported that the 70% stenosed target lesion was located in a massively calcified left anterior descending artery (lad).It was noted that the balloon was formed to an arrow, which did not allow to push it further, but not back.No additional patient complications were reported in relation to this event.
 
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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 Key11271855
MDR Text Key230019719
Report Number2134265-2021-01159
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,foreig
Type of Report Initial,Followup
Report Date 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3851
Device Catalogue Number3851
Was Device Available for Evaluation? No
Date Manufacturer Received02/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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