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 Break (1069)

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

Event Date 10/18/2023

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.A 15 mm x 3.50 mm wolverine balloon was selected for procedure.During the introduction of the device, the shaft was broken into two parts.The patient was in stable condition during the whole procedure.The procedure completed successfully with another wolverine device.There were no patient complications reported and the patient was stable post procedure.

Event Description

It was reported that shaft break occurred.A 15 mm x 3.50 mm wolverine balloon was selected for procedure.During the introduction of the device, the shaft was broken into two parts.The patient was in stable condition during the whole procedure.The procedure completed successfully with another wolverine device.There were no patient complications reported and the patient was stable post procedure.It was further reported that the 90% stenosed lesion was located in a mildly tortuous and severely calcified left main (lm) and left anterior descending artery (lad).The detached portion of the device was pulled out as end was visible and removed.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Visual/tactile inspection identified a hypotube break 22.2 cm distal to the distal end of the strain relief along with a hypotube kink 20.5 cm distal to the distal end of the strain relief.Visual/tactile inspection of the balloon and shaft polymer extrusion identified no damages.Microscopic analysis of the ballon material identified no tears or pinholes in the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No issues identified during examination of the extrusion shaft.The tip showed no signs of damage.A microscopic examination of the proximal and distal markerbands identified no damage.

• 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: 18074286
• MDR Text Key: 327416730
• Report Number: 2124215-2023-61724
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: HU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0031679987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2023
• 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 Age: 73 YR
• Patient Sex: Male