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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 3850
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/15/2019
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years of age or older.
 
Event Description
It was reported that a partial blade detachment had occurred.A percutaneous coronary intervention was being performed on a lesion in the left anterior descending artery.The 6mm x 3.5mm wolverine coronary cutting balloon was inflated 4-5 times to a value below the devices rated burst pressure to treat the targeted lesion.Upon removing the wolverine, the device caught in the 7f guide extension catheter and one of the blades was damaged.The partial detachment of the blade was noted outside of the patient's body.The procedure was completed without further issue or patient injury.
 
Event Description
It was reported that a partial blade detachment had occurred.A percutaneous coronary intervention was being performed on a lesion in the left anterior descending artery.The 6mm x 3.5mm wolverine coronary cutting balloon was inflated 4-5 times to a value below the devices rated burst pressure to treat the targeted lesion.Upon removing the wolverine, the device caught in the 7f guide extension catheter and one of the blades was damaged.The partial detachment of the blade was noted outside of the patient's body.The procedure was completed without further issue or patient injury.
 
Manufacturer Narrative
Age at time of event: 18 years of age or older.Device returned to manufacturer: the wolverine was returned and analysis was completed.A visual and tactile examination of the catheter shaft identified no kinks or damage along the shaft.A visual and microscopic examination of the balloon material identified that some sections of the blades were detached and were not returned for analysis: 5mm approximate of the proximal section of blade detached on one strip; on a different strip, 1mm of blade from the distal end of a proximal strip and 2mm of blade from the distal end of the same strip.All pads were fully bonded onto the balloon.Initial attempts to inflate the balloon failed.As a result the device was soaked in a heated water bath in order to dissolve the potential of solidified contrast media inside the inflation lumen.When the device was removed and an attempt was made to inflate the balloon a pinhole leak was identified.The pinhole was located at the distal end of one of the pads where a segment of blade detached.Microscopic examination identified no issues with the balloon material which could potentially have contributed to the pinhole leak.An examination of the markerbands identified no issues which could potentially have contributed to the complaint incident.
 
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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 Key8588454
MDR Text Key144414002
Report Number2134265-2019-04381
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 07/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3850
Device Catalogue Number3850
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2019
Initial Date Manufacturer Received 04/15/2019
Initial Date FDA Received05/07/2019
Supplement Dates Manufacturer Received06/29/2019
Supplement Dates FDA Received07/22/2019
Patient Sequence Number1
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