MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7590

Device Problems Break (1069); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2020

Event Type  malfunction  

Event Description

It was reported that a shaft break occurred.A percutaneous coronary intervention was being performed on a 5x400mm, concentric, in-stent re-stenosed lesion in the left femoral artery.There was some resistance during advancement of the 4.00mm x 20mm maverick balloon and the shaft broke outside of the patient.The procedure was successfully completed with a different device without issue or patient injury.

Manufacturer Narrative

Returned product consisted of a maverick 2 balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.The hypotube was separated 8cm from the hub.The hypotube was twisted.Microscopic examination revealed damage to the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that could have contributed to the difficulty to advance.

Event Description

It was reported that a shaft break occurred.A percutaneous coronary intervention was being performed on a 5x400mm, concentric, in-stent re-stenosed lesion in the left femoral artery.There was some resistance during advancement of the 4.00mm x 20mm maverick balloon and the shaft broke outside of the patient.The procedure was successfully completed with a different device without issue or patient injury.

• Brand Name: MAVERICK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9668077
• MDR Text Key: 179234819
• Report Number: 2134265-2020-00951
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729370246
• UDI-Public: 08714729370246
• Combination Product (y/n): N
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2021
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0022701214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 72