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

Model Number 3851

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)

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

Event Date 09/27/2023

Event Type  malfunction  

Event Description

It was reported that blade detachment occurred.During preparation of a percutaneous coronary intervention (pci) procedure, it was noted the wolverine blades were detached.The wolverine was replaced to complete the procedure with no patient complications.

Manufacturer Narrative

Update to b5 and h6 - update to event description and coding event was initially reported as a detachment, then a defect with no detachment, however upon receipt a detachment was noted.When good faith effort attempt was made again, the account confirmed that they did note a detachment.Therefore, coding and b5 has been updated to reflect this update.Device evaluated by manufacturer: the device was returned to the cis for analysis.A visual, tactile and microscopic examination was performed.Device analysis identified that a v-shaped tear, measuring approximately 8mm in length, was present in the balloon material.None of the balloon material had detached.Further analysis identified that one entire blade segment, at the site of the tear in the balloon material had detached and was not returned for analysis.A microscopic examination of the site of the detached blade confirmed that the blade pad was intact.Further examinations confirmed that no issues existed with the other two blade segments.

Event Description

It was reported that blade damage occurred.During preparation of a percutaneous coronary intervention (pci) procedure, it was noted the wolverine blades were detached.The wolverine was replaced to complete the procedure with no patient complications.

Manufacturer Narrative

Update to b5 and h6 - update to event description and coding.

Event Description

It was reported that blade damage occurred.During preparation of a percutaneous coronary intervention (pci) procedure, it was noted the wolverine blades were detached.The wolverine was replaced to complete the procedure with no patient complications.It was further reported that the device was not completely detached, but an undetermined malfunction occurred.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17966097
• MDR Text Key: 326074268
• Report Number: 2124215-2023-58083
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2023

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 Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0030203779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 10/23/2023; 12/01/2023
• Supplement Dates FDA Received: 11/20/2023; 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2022
• 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