MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number 3852

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/13/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified no damage to the balloon.All blades were securely bonded and no damage to the blades were noted.No kinks or damages were identified along the hypotube.An examination of the wire lumen found that the inner/wire lumen was bunched.A hole /protrusion was identified in the outer extrusion just proximal to the inner bunching (consistent with a wire puncturing through the inner and outer due to the bunching).No damage was observed along the tip.A 0.014 test guidewire was unable to be loaded due to the presence of damage to the inner lumen of the shaft polymer extrusion.A visual and microscopic examination found no issue with the marker bands.

Event Description

Reportable based on device analysis completed on 24sep2021.It was reported that a guidewire lumen issue occurred.A percutaneous coronary intervention was being performed.This 15mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the non boston scientific guidewire did not enter the wire lumen of the device.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed that the device has a hole /protrusion in the outer extrusion.

• 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 Key: 12577136
• MDR Text Key: 274758606
• Report Number: 2134265-2021-12451
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2023
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0027466829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: ASAHI INTEC SION