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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 Problems Material Rupture (1546); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/20/2022
Event Type  malfunction  
Event Description
It was reported that the balloon ruptured, and blade part was damaged.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, at eleventh inflation, it was noted that the balloon ruptured at 8atm.The device was removed using the normal method and a damage on the blade part was also noted.The procedure was completed with a different device.No complications were reported and patient was good post procedure.
 
Event Description
It was reported that the balloon ruptured, and blade part was damaged.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, at eleventh inflation, it was noted that the balloon ruptured at 8atm.The device was removed using the normal method and a damage on the blade part was also noted.The procedure was completed with a different device.No complications were reported and patient was good post procedure.It was further reported there was no blade damage.
 
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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
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key14957868
MDR Text Key295506231
Report Number2134265-2022-07722
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 07/25/2022
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 Date02/21/2024
Device Model Number3852
Device Catalogue Number3852
Device Lot Number0028912374
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/20/2022
Initial Date FDA Received07/08/2022
Supplement Dates Manufacturer Received07/19/2022
Supplement Dates FDA Received07/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/21/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDEWIRE - SION BLUE, SION BLACK; GUIDEWIRE - SION BLUE, SION BLACK; IMAGING CATHETER - ALTAVIEW; INFLATION DEVICE - NIPRO; INFLATION DEVICE - NIPRO; INTRODUCER SHEATH - 6F TERUMO; INTRODUCER SHEATH - 6F TERUMO
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