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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 Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/13/2022
Event Type  malfunction  
Event Description
It was reported that a shaft pinhole occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified left coronary artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the applied pressure only reached at 2atm.The device was simply pulled out from the patient's body.It was then noted that the balloon shaft has a pinhole.The procedure was completed with another of same device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon wings were found to tightly wrapped and had not been subjected to positive pressure.There were no issues noted with the balloon material.All blades were securely bonded and no damage to the blades were noted.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination was completed on the shaft polymer extrusion of the device.No issues were visually noticeable on the shaft polymer of the device.However, when the device was attached to an encore inflation device and during an attempt to inflate the balloon of the device, a pinhole was noted on the outer extrusion of the shaft polymer extrusion at approx.10cm distal to the guidewire port.No issues were noted with the inner extrusion.A visual and tactile examination of the hypotube identified no issues.
 
Event Description
It was reported that a shaft pinhole occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified left coronary artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the applied pressure only reached at 2atm.The device was simply pulled out from the patient's body.It was then noted that the balloon shaft has a pinhole.The procedure was completed with another of same device.No patient complications were 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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13893499
MDR Text Key287908526
Report Number2134265-2022-03385
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 05/04/2022
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 Date11/18/2023
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0028407571
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/14/2022
Initial Date FDA Received03/24/2022
Supplement Dates Manufacturer Received04/28/2022
Supplement Dates FDA Received05/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2021
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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