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

Model Number 7590

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 12/15/2019

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.A 2.00mm x 20mm maverick balloon catheter was selected for use.However, during unpacking, the shaft of the balloon was broken.The procedure was completed with another of the same device.No patient complications nor injuries were reported and the patient's status was stable.

Manufacturer Narrative

Device was evaluated by mfr: 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 is separated 82.9cm from the hub.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that shaft break occurred.A 2.00mm x 20mm maverick balloon catheter was selected for use.However, during unpacking, the shaft of the balloon was broken.The procedure was completed with another of the same device.No patient complications nor injuries were reported and the patient's status 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: 9633134
• MDR Text Key: 178380837
• Report Number: 2134265-2020-00246
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729370161
• UDI-Public: 08714729370161
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2022
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0024151171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 76