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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 Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/21/2022
Event Type  malfunction  
Event Description
It was reported that a balloon ruptured.The 50% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal to mid left anterior descending artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that there was no problem in crossing the lesion, but when pressure was applied up to 8 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No complications reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Based on the potential root causes identified in the fmea and the complaint report, the following attributes were examined: a visual examination identified that the balloon wings were in a deflated state and had been subjected to positive pressure.A microscopic examination of the balloon found no tears or holes in the balloon material.The device was attached to a boston scientific encore inflation unit and during an attempt to inflate the balloon a pinhole leak confirmed.The pinhole leak was confirmed in the distal transition zone in the balloon.The blades of the device were visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon surface.A visual and tactile examination found no kinks along the length of the hypotube.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.
 
Event Description
It was reported that a balloon ruptured.The 50% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal to mid left anterior descending artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that there was no problem in crossing the lesion, but when pressure was applied up to 8 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No complications reported.
 
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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 IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15941133
MDR Text Key306002825
Report Number2124215-2022-51122
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 01/17/2023
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
Device Lot Number0030371785
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/25/2022
Initial Date FDA Received12/08/2022
Supplement Dates Manufacturer Received01/12/2023
Supplement Dates FDA Received01/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2022
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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