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 Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile examination of the hypotube confirmed that a break had occurred in the hypotube shaft.The break was located at 81.5cm distal to the distal end of the strain relief.The distal section of the hypotube break including the distal extrusion, balloon and tip sections were not received for analysis.The main section of the hypotube was kinked at different locations along its length.A microscopic examination of the break site identified that the break occurred as a result of a severe kink in the hypotube.The edge of the break site displayed a kink formation.

Event Description

It was reported that a device separation occurred.The 94% stenosed, 11mm x 3.0mm in diameter, target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery (lad).A 10mm x 3.00mm wolverine coronary cutting balloon was selected for percutaneous coronary intervention (pci).During the procedure, it was noted that the balloon delivery shaft was kinked and the hypotube was detached.The detached portion of the hypotube was not left inside the patient's body.The procedure was completed with a different device.There were no complications reported and the patient was stable.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17501554
• MDR Text Key: 321641346
• Report Number: 2124215-2023-40697
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• 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: 0030114546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2022
• 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 Age: 48 YR
• Patient Sex: Male
• Patient Weight: 85 KG