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

Model Number	7590
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.A percutaneous coronary intervention was being performed on a 5x400mm, concentric, in-stent re-stenosed lesion in the left femoral artery.There was some resistance during advancement of the 4.00mm x 20mm maverick balloon and the shaft broke outside of the patient.The procedure was successfully completed with a different device without issue or patient injury.
Additional Manufacturer Narrative
Returned product consisted of a maverick 2 balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.The hypotube was separated 8cm from the hub.The hypotube was twisted.Microscopic examination revealed damage to the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that could have contributed to the difficulty to advance.
Event or Problem Description
It was reported that a shaft break occurred.A percutaneous coronary intervention was being performed on a 5x400mm, concentric, in-stent re-stenosed lesion in the left femoral artery.There was some resistance during advancement of the 4.00mm x 20mm maverick balloon and the shaft broke outside of the patient.The procedure was successfully completed with a different device without issue or patient injury.

• Brand Name: 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: 9668077
• Report Number: 2134265-2020-00951
• Device Sequence Number: 2800603
• Product Code: LOX
• UDI-Device Identifier: 08714729370246
• UDI-Public: 08714729370246
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 03/06/2020

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: 09/24/2021
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0022701214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 72