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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.5mm x 15mm quantum maverick balloon catheter was advanced for dilatation; however, it was noted that the balloon delivery shaft was fractured.The device was completely removed and the procedure was completed with another of the same device.No patient complications reported and the patient's status was stable.
Event or Problem Description
It was reported that shaft break occurred.A 3.5mm x 15mm quantum maverick balloon catheter was advanced for dilatation; however, it was noted that the balloon delivey shaft was fraqctured.The device was completely removed and the procedure was completed with another of the same device.No patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The balloon was tightly folded with a product mandrel in the wire lumen.There were numerous hypotube kinks.The hypotube was separated 73.5cm from the hub.The separated ends of the hypotube was ovaled indicating the hypotube was kinked prior to separating.The reported break 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: 9482417
• Report Number: 2134265-2019-15824
• Device Sequence Number: 209053
• Product Code: LOX
• UDI-Device Identifier: 08714729392804
• UDI-Public: 08714729392804
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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: 05/16/2022
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0023808102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 70