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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 3852
Device Problem Material Rupture (1546)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified proximal to mid left anterior descending artery.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon first inflation at 12 atmospheres for 10 seconds.The balloon was removed from the patient's body without any problem using the normal method and the procedure was completed with a different device.No complications were reported and the patient was in good condition after the procedure.
 
Manufacturer Narrative
E1 - initial reporter address: (b)(6).Device evaluated by mfr: the device was returned for analysis.A visual examination identified that the balloon was not folded and there was a build-up of solidified contrast media inside the balloon.As a result, the device was placed in a water bath at 37 degrees celsius in order to soften the contrast media to facilitate balloon inflation/leakage testing.The returned device was then attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon when liquid was observed to be leaking from a balloon pinhole.The pinhole was located at 1mm distal from the proximal markerband.An examination of the balloon material identified no issues which could potentially have contributed to the pinhole leak.The rated burst pressure for this device is 12 atmospheres.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 and of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.
 
Event Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified proximal to mid left anterior descending artery.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon first inflation at 12 atmospheres for 10 seconds.The balloon was removed from the patient's body without any problem using the normal method and the procedure was completed with a different device.No complications were reported and the patient was in good condition after the procedure.
 
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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 Key11236807
MDR Text Key228917447
Report Number2134265-2021-00842
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 02/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/18/2022
Device Model Number3852
Device Catalogue Number3852
Device Lot Number0026206465
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2021
Date Manufacturer Received02/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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