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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 11/20/2023
Event Type  malfunction  
Event Description
It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 15mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, at first inflation, it was noted that the balloon ruptured at 6atm within 30 seconds.The device was removed using normal method without any problem.The procedure was completed with a different device.No complications were reported, and patient was good post procedure.
 
Manufacturer Narrative
A2.Age at time of event: 18 years or older.
 
Manufacturer Narrative
A2: age at time of event: 18 years or older.Device evaluated by manufacturer: the device was returned for analysis.Visual and tactile inspection was performed.A blood was identified inside the balloon.No issues identified with the hypotube shaft.The shaft polymer extrusion has no kinks or damages.A detailed microscopic examination of the balloon material identified a pinhole 1mm proximal from the proximal markerband.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No issues identified during examination of the extrusion shaft.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.An attempt was then made to inflate the balloon to 12 atmospheres as per wolverine instruction for used using the inflation aid, however, a leak was located 1mm proximal from proximal markerband.
 
Event Description
It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 15mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, at first inflation, it was noted that the balloon ruptured at 6atm within 30 seconds.The device was removed using normal method without any problem.The procedure was completed with a different device.No complications were reported, and patient was good post 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
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18226379
MDR Text Key329200586
Report Number2124215-2023-67334
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 Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/29/2023
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 Number3852
Device Catalogue Number3852
Device Lot Number0030741435
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/20/2023
Initial Date FDA Received11/29/2023
Supplement Dates Manufacturer Received12/18/2023
Supplement Dates FDA Received12/29/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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