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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 Leak/Splash (1354); Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2021
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that a balloon rupture occurred.Vascular access was via the right femoral artery.The 90% stenosed, 73 x 3.50 mm, concentric, de novo, target lesion was located in the moderately tortuous and severely calcified right coronary artery with a bend >= 90 degrees.Following pre dilatation with a 12 x 2.00mm maverick balloon, there was 65% residual stenosis.When a 10mm x 2.00mm wolverine coronary cutting balloon was advanced to crack the calcium, significant resistance was encountered.On the first inflation of the wolverine balloon at 6atm, the balloon ruptured within less than 10 seconds and blood was leaking from the back side.The device was removed and the procedure completed with another of same device.No patient complications were reported and patient was stable post procedure.
 
Event Description
It was reported that a balloon rupture occurred.Vascular access was via the right femoral artery.The 90% stenosed, 73 x 3.50 mm, concentric, de novo, target lesion was located in the moderately tortuous and severely calcified right coronary artery with a bend >= 90 degrees.Following pre dilatation with a 12 x 2.00mm maverick balloon, there was 65% residual stenosis.When a 10mm x 2.00mm wolverine coronary cutting balloon was advanced to crack the calcium, significant resistance was encountered.On the first inflation of the wolverine balloon at 6atm, the balloon ruptured within less than 10 seconds and blood was leaking from the back side.The device was removed and the procedure completed with another of same device.No patient complications were reported and patient was stable post procedure.
 
Manufacturer Narrative
A2 - age at time of event: 18 years or older.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.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon and liquid was observed to be leaking from a balloon pinhole located at 5mm distal to the proximal marker band.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.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 of the device were visually and microscopically examined, and damage was noted of the tip of this device.
 
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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 Key11419053
MDR Text Key234954764
Report Number2134265-2021-02399
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 04/27/2021
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 Expiration Date12/17/2022
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0026537336
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2021
Initial Date Manufacturer Received 02/15/2021
Initial Date FDA Received03/05/2021
Supplement Dates Manufacturer Received04/07/2021
Supplement Dates FDA Received04/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BALLOON: MAVERICK 2.0X12; BALLOON: MAVERICK 2.0X12; BALLOON: NC QUNATUM APEX; BALLOON: NC QUNATUM APEX; GUIDE CATHETER: 7F AL 1; GUIDE CATHETER: 7F AL 1; GUIDEWIRE: SION BLUE & MARVEL; GUIDEWIRE: SION BLUE & MARVEL; STENT: PROMUS ELITE; STENT: PROMUS ELITE; BALLOON: MAVERICK 2.0X12; BALLOON: NC QUNATUM APEX; GUIDE CATHETER: 7F AL 1; GUIDEWIRE: SION BLUE & MARVEL; STENT: PROMUS ELITE
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