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

Model Number	7020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9678358
• Report Number: 2134265-2020-00952
• Device Sequence Number: 2837311
• Product Code: LOX
• UDI-Device Identifier: 08714729392910
• UDI-Public: 08714729392910
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 75