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	12/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 75% stenosed, 3.0mmx38mm target lesion was located in the tortuous and moderately calcified proximal and middle of the left anterior descending artery.A 3.5mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, during procedure, the balloon shaft delivery system got kinked and 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.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick catheter in 2 pieces.There was blood in the wire lumen, and the balloon was tightly folded.Analysis for the tip, balloon, inner/outer shaft, hypotube, and hub included microscopic and visual inspection.Inspection revealed a complete separation in the hypotube located 49.7 cm from the tip, and there were kinks in the hypotube located 47.5cm and 52.4cm from the tip.The fracture faces of the separated ends indicate that the device was kinked prior separation.Inspection of the rest of the device found no other damage or defect.
Event or Problem Description
It was reported that shaft break occurred.The 75% stenosed, 3.0mmx38mm target lesion was located in the tortuous and moderately calcified proximal and middle of the left anterior descending artery.A 3.5mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, during procedure, the balloon shaft delivery system got kinked and 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.

• 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: 9639711
• Report Number: 2134265-2020-00630
• Device Sequence Number: 16836224
• 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): 03/02/2020

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: 07/28/2022
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0024177731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 82