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 Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 11/05/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address 1- (b)(6).

Event Description

It was reported that the stuck in lesion and detachment occurred.The tight target lesion was located in the left main coronary artery.Following pre-dilation with a non-compliant balloon, a 10mmx3.25mm wolverine coronary cutting balloon was used.While the balloon was being deflated, the blades got stuck in the lesion and the physician tried to inflate again.A detachment also occurred and everything was withdrawn.The procedure was successfully completed and there were no patient complications.

Event Description

It was reported that the stuck in lesion and detachment occurred.The tight target lesion was located in the left main coronary artery.Following pre-dilation with a non-compliant balloon, a 10mmx3.25mm wolverine coronary cutting balloon was used.While the balloon was being deflated, the blades got stuck in the lesion and the physician tried to inflate again.A detachment also occurred and everything was withdrawn.The procedure was successfully completed and there were no patient complications.

Manufacturer Narrative

E1.Initial reporter address 1- (b)(6).The wolverine cb mr, ous 10mmx3.25mm was returned for analysis.A visual and microscopic examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.Three blades were present on the balloon surface.The first blade had approximately 3mm of the proximal section detached and not returned.The blade pad was fully intact and no other damages were observed to the first blade.There was no damage observed on the second and third blades; the blades and pads were fully bonded.A visual and tactile examination found multiple kinks along the length of the hypotube.A visual, microscopic and tactile examination found no damage along the shaft polymer extrusion.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16091215
• MDR Text Key: 306681194
• Report Number: 2124215-2022-55713
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• 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: 0029808271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2022
• 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
• Patient Race: Asian