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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 Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2022
Event Type  malfunction  
Event Description
Reportable based on device analysis completed on 07feb2023.It was reported that a device kinked occurred.The target lesion was located in the left anterior descending artery.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the device was kinked.The device was removed with the normal method and the procedure was completed with another of the same device.No patient complications reported.However, device investigations revealed a perforation in the outer extrusion at 5.6cm proximal from the tip.
 
Manufacturer Narrative
Device evaluated by manufacturer: a wolverine cb 10mmx3.50mm, catheter was returned for analysis.Based on the potential hazards/failure modes identified and the complaint report, the following attributes were examined: a visual examination identified that the balloon was folded.A microscopic examination of the balloon material and marker bands 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 found a kink in the hypotube.The kink was located at 65.5cm distal from the strain relief.An examination of the distal extrusion identified that the distal extrusion was kinked at 9cm; 9.4cm and 10cm distal from the port.A microscopic examination of the inner/wire lumen noted bunching of the extrusion at approximately 5.2cm proximal from the tip.Further examinations noted a perforation in the outer extrusion at 5.6cm proximal from the tip.It is likely that as a result of the bunching in the wire lumen, when an attempt was made by the physician to pass the wire through the bunched lumen, it resulted in the guidewire puncturing out through the inner and outer lumen.The marker bands 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 IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16409185
MDR Text Key309878943
Report Number2124215-2023-07767
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
Report Date 02/21/2023
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 Number0029531585
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/07/2023
Initial Date FDA Received02/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/05/2022
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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