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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 Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2021
Event Type  malfunction  
Event Description
It was reported that a balloon rupture occurred.A 15mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured.The device was removed without any problem by using the normal method.The procedure was completed with another of the same device.There were no complications reported and patient was in good condition post procedure.
 
Event Description
It was reported that a balloon rupture occurred.A 15mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured.The device was removed without any problem by using the normal method.The procedure was completed with another of the same device.The patient was in good condition post procedure.
 
Manufacturer Narrative
The device was returned for analysis.A visual examination identified that the balloon was in a deflated state.Blood was visible inside the balloon material and along the inflation lumen.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not inflate due to the presence of solidified media in the inflation lumen.The device was placed in the water bath in order to allow the media to soften.The device was removed from the water bath and again an inflation attempt was made.Liquid was observed to be leaking from a balloon pinhole located at the proximal edge of the proximal markerband.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 identified no issues.A visual and tactile examination identified no issues.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.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12828156
MDR Text Key280881882
Report Number2134265-2021-14443
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/17/2021
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 Date06/10/2023
Device Model Number3852
Device Catalogue Number3852
Device Lot Number0027466830
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/02/2021
Initial Date FDA Received11/17/2021
Supplement Dates Manufacturer Received12/07/2021
Supplement Dates FDA Received12/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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