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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 Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/27/2018
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that blade lifting occurred.A 10mm x 3.50mm wolverine coronary cutting balloon monorail was used to dilate a target lesion and on the second inflation at 16 atmospheres for 30 seconds, the blade was damaged.The blade had lifted from the balloon.The procedure was completed with this device.No patient complications were reported and the patient status was good.
 
Manufacturer Narrative
Device evaluated by mfr: a visual and microscopic examination was performed on the returned device which revealed a section of one of the blades, approximately 3mm in length was partially detached from the proximal end of the balloon material and lifted distally.The remaining section of blade measuring approximately7mm in length was undamaged and fully bonded to the balloon material.The entire 10mm of blade was accounted for.The entire blade pad remained fully bonded to the balloon material.The damage identified can potentially be a result of the resistance encountered during the withdrawal of the device.All other blades were intact and fully bonded to the balloon material.No issues were noted with the blades or pads that could have contributed to the complaint incident.A visual and microscopic examination of the balloon noted that the balloon was unfolded and had been subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 4mm distal to the distal edge of the distal markerband and extending approximately 8mm proximally across the balloon material.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint issues were noted with the balloon material that could have contributed to the complaint incident.No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination identified no kinks or issues along the length of the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that blade lifting occurred.A 10mm x 3.50mm wolverine coronary cutting balloon monorail was used to dilate a target lesion and on the second inflation at 16 atmospheres for 30 seconds, the blade was damaged.The blade had lifted from the balloon.The procedure was completed with this device.No patient complications were reported and the patient status was good.
 
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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 Key8267551
MDR Text Key133747349
Report Number2134265-2019-00174
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 03/06/2019
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 Number3851
Device Catalogue Number3851
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2019
Initial Date Manufacturer Received 12/28/2018
Initial Date FDA Received01/22/2019
Supplement Dates Manufacturer Received02/20/2019
Supplement Dates FDA Received03/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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