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

Model Number	7010
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned product consisted of a quantum maverick balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a separation on the hypotube 45.6cm from the hub and it appears to have been kinked prior to separating.There is a kink on the hypotube 42.7cm from the hub.There are two kinks on the hypotube 56cm and 59.5cm from the tip.The inflation lumen is partially flattened 26.3cm from the tip.Microscopic examination revealed damage to the tip.There is blood present in the guidewire lumen and on the balloon folds.The balloon is still tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported crossing difficulty.
Event or Problem Description
Reportable based on device analysis completed on 04-apr-2019.It was reported that crossing difficulty was encountered.The 85% stenosed, 2.75mm x 12mm target lesion was located in the moderately tortuous and calcified left anterior descending artery.A 2.75mm x 12mm quantum maverick balloon catheter was advanced but failed to cross the lesion.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.However, returned device analysis revealed a separated 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: 8561284
• Report Number: 2134265-2019-04507
• Device Sequence Number: 1731954
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2019

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: 09/16/2021
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 22661686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 74