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

Model Number	7015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10938107
• Report Number: 2134265-2020-16848
• Device Sequence Number: 3190129
• Product Code: LOX
• UDI-Device Identifier: 08714729392774
• UDI-Public: 08714729392774
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 02/02/2021
• 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: 55