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

Model Number 7020

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2020

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.A 3.5mm x 20mm quantum maverick balloon catheter was selected for use.However, after unpacking the device, it was noticed that the shaft was fractured.No patient complications were reported and the patient was stable.

Manufacturer Narrative

The returned device consisted of a quantum maverick balloon catheter.The device was missing the hub, and the balloon was tightly folded.Analysis of the tip, balloon, inner/outer shaft, and hypotube included microscopic and visual inspection.Inspection revealed numerous kinks in the hypotube and that 106cm of the device returned.The proximal end (separated edge) of the damaged hypotube was ovalized, consistent with being kinked prior to separating.The reported fracture was confirmed.

Event Description

It was reported that shaft break occurred.A 3.5mm x 20mm quantum maverick balloon catheter was selected for use.However, after unpacking the device, it was noticed that the shaft was fractured.No patient complications were reported and the patient was stable.

• 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: 9678358
• MDR Text Key: 179242659
• Report Number: 2134265-2020-00952
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392910
• UDI-Public: 08714729392910
• 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: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2022
• Device Model Number: 7020
• Device Catalogue Number: 7020
• Device Lot Number: 0024488824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Date Manufacturer Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 75