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

Model Number 3851

Device Problem Material Twisted/Bent (2981)

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

Event Date 07/06/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(6).Device evaluated by mfr: the device was returned for analysis.A visual examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.An examination of the blades noted that approximately 1mm of the distal end of a distal blade section was missing.All other blades were intact and all blade pads were fully bonded.A visual and tactile examination found no kinks or damages.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.

Event Description

Reportable based on device analysis completed on (b)(6) 2021.It was reported that the balloon blade was bent.A 10mmx2.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the blade of the balloon was damaged or bent when taken out of the loop.The device was completely removed from the patient's body.No patient complications were reported.However, device analysis revealed that 1mm of the distal end of a distal blade section was missing.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway
• 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: 12419107
• MDR Text Key: 269798239
• Report Number: 2134265-2021-10951
• 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: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2023
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0027212253
• 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: 04/27/2021
• 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