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	11/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft fracture occurred.The 92% stenosed target lesion was located in the right coronary artery.A 3.25mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, it was noted that the balloon delivery shaft was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The balloon was tightly folded and there was blood in the wire lumen.The tip, balloon, inner/outer shaft, and hypotube were microscopically and visually inspected.Inspection revealed numerous kinks in the hypotube, and a separation in the hypotube located 65.1 cm from the tip of the device.The fracture faces of the separation were ovalized, as if kinked prior to separating.Inspection of the remainder of the device revealed no other damage or irregularities.
Event or Problem Description
It was reported that shaft fracture occurred.The 92% stenosed target lesion was located in the right coronary artery.A 3.25mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, it was noted that the balloon delivery shaft was fractured.The procedure was completed with another of the same device.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: 8126216
• Report Number: 2134265-2018-63424
• Device Sequence Number: 19265508
• Product Code: LOX
• UDI-Device Identifier: 08714729392798
• UDI-Public: 08714729392798
• 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): 01/15/2019

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: 05/02/2021
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0022071131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 75