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

Model Number 3851

Device Problem Material Deformation (2976)

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

Event Date 06/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device evaluated by mfr.: the complaint device was returned for analysis.Blades and pads, a visual examination identified that the balloon appeared to have been inflated and was not tightly folded.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 of the device.A hypotube break was identified at 22.8cm distal from the strain relief.Multiple hypotube kinks were also noted.A visual and tactile examination was completed, and no issues were noted.

Event Description

Reportable based on device analysis completed on 13aug2021.It was reported that shaft kink occured.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 10mmx3.00mm wolverine cutting balloon was selected for use.During the procedure, it was noted that the shaft was kinked at mid part of the catheter.The device was removed without any issues.The procedure was completed with a different device.No patient complications were reported.However, returned device analysis revealed hypotube break.

• 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: 12375594
• MDR Text Key: 268452848
• Report Number: 2134265-2021-10822
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2023
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0026852555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2021
• 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