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

Model Number 7585

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

Age at the time of event: 18 years or older.

Event Description

It was reported that shaft break occurred.A 2.00mm x 15mm maverick 2 balloon catheter was selected for a coronary angioplasty procedure in the right coronary artery (rca).During unpacking, it was noted that the shaft was broken.The procedure was completed with a different device.No patient complications were reported and the patient was stable.

Manufacturer Narrative

Age at the time of event: 18 years or older.Device evaluated by mfr.: returned product consisted of a maverick 2 balloon catheter.The hypotube was separated 73.5cm from the hub, the separated ends were ovaled indicating that the hypotube was kinked prior to separation.There were numerous kinks throughout the hypotube.The reported separation was confirmed.

Event Description

It was reported that shaft break occurred.A 2.00mm x 15mm maverick 2 balloon catheter was selected for a coronary angioplasty procedure in the right coronary artery (rca).During unpacking, it was noted that the shaft was broken.The procedure was completed with a different device.No patient complications were reported and the patient was stable.

• 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: 9410198
• MDR Text Key: 175367036
• Report Number: 2134265-2019-14607
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729370062
• UDI-Public: 08714729370062
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2022
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0023699249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Date Manufacturer Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1