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

Model Number 7015

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2020

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.While a 2.75mm x 15mm quantum maverick balloon catheter was being unpacked, the shaft broke.The procedure was completed with another of the same device.

Event Description

It was reported that shaft break occurred.While a 2.75mm x 15mm quantum maverick balloon catheter was being unpacked, the shaft broke.The procedure was completed with another of the same device.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a quantum maverick mr balloon catheter.The balloon was tightly folded.Analysis of the tip, balloon, inner/outer shaft and hypotube included microscopic and visual inspection.Inspection revealed the hypotube fractured 98.1cm from the tip of the device, and there were numerous kinks in the hypotube.The fracture faces were ovalized, suggesting the area had been kinked prior to separating.Inspection of the rest of the device found no other damage or defects.The reported shaft fracture was confirmed.

• Brand Name: QUANTUM 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: 10938107
• MDR Text Key: 219318341
• Report Number: 2134265-2020-16848
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392774
• UDI-Public: 08714729392774
• 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: 02/02/2021

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: 03/10/2023
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0025332956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/03/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 55