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

Model Number	7015
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: received product consisted of a quantum maverick balloon catheter in two pieces.The balloon was loosely folded and there was fluid in the balloon.The tip, balloon, proximal weld, inner/outer shafts, and hypotube were microscopically and visually inspected.Inspection revealed a complete separation in the hypotube located 23.8 cm from the strain relief, numerous kinks in the hypotube and tip damage (flared).The fracture faces of the separation were ovaled, as if kinked prior to separation.Inspection of the rest of the device found no other damage.
Event or Problem Description
Reportable based on device analysis completed on 09may2019.It was reported that crossing difficulties were encountered.The target lesion was located in a coronary artery.A 2.75mm x 15mm quantum maverick balloon catheter was advanced for dilatation, but failed to cross the lesion even after several attempts.The procedure was completed with a different device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed a complete separation of the hypotube.

• 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: 8658660
• Report Number: 2134265-2019-06176
• Device Sequence Number: 2566958
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2019

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: 08/28/2020
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0021069104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 05/31/2019
• 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: 71