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 Advance (2920); Material Deformation (2976)

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

Event Date 04/14/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis without the distal shaft containing the balloon with blades, tip, and the inner/outer shaft polymer extrusions.A visual examination on the balloon, blades, pads, tip, marker band and shaft polymer extrusion could not be performed as this section of the device was not returned.A visual and tactile examination was completed on the shaft of the device and multiple hypotube kinks were noted.Additionally, a complete hypotube break at 68 cm distal from the strain relief was noted.

Event Description

Reportable based on device analysis completed on (b)(6) 2022.It was reported that the delivery shaft got kinked.The 11mm x 2.5mm in diameter, 92% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, upon advancing, a resistance was felt, and delivery shaft kinked was noted.The device was removed intact.The procedure was completed with a different device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that the hypotube was completely broke 68cm distal from the strain relief.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15402870
• MDR Text Key: 304537904
• Report Number: 2124215-2022-33363
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2022

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 Expiration Date: 12/06/2023
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0028503034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2021
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 83 KG