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

Model Number	7010
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned product consisted of a quantum maverick balloon catheter.There was blood in the balloon.There were numerous hypotube kinks.The shaft was buckled throughout the distal shaft.Functional testing was performed by applying pressure with a water filled inflation device and found that water was leaking at the most proximal buckled location.Microscopic examination of the shaft revealed a hole in the outer shaft near the distal end of the core wire which indicates at some point the shaft buckled causing the core wire to puncture through the outer shaft.
Event or Problem Description
Reportable based on device analysis completed on 10jan2020.It was reported that a kink occurred.The 99% stenosed, 16mmx2.75mm target lesion was located in the severely tortuous and calcified left main coronary artery.A 2.75mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, the balloon delivery shaft was kinked.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed a hole in the outer shaft.

• 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: 9643414
• Report Number: 2134265-2020-00689
• Device Sequence Number: 1873706
• Product Code: LOX
• UDI-Device Identifier: 08714729392668
• UDI-Public: 08714729392668
• 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
• Report Date (Section B): 01/29/2020

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: 05/05/2022
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0023744696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 65