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

Model Number	7575
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date was not reported and approximated (b)(6) 2018.
Event or Problem Description
Reportable based on device analysis completed on 24-oct-2018.A 2.50mm x 9mm maverick 2 balloon catheter was returned with no reported allegation, however, investigation results revealed the shaft detached/separated.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.The hypotube is separated 66.1cm from the hub.Microscopic examination revealed no additional damages.There is blood present in the guide wire lumen and on the balloon folds.The balloon is partially loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found multiple kinks and a separated hypotube.The hypotube appeared to be kinked prior to separation.

• 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: 8090978
• Report Number: 2134265-2018-62871
• Device Sequence Number: 11114275
• Product Code: LOX
• UDI-Device Identifier: 08714729369899
• UDI-Public: 08714729369899
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2018

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: 07/31/2020
• Device Model Number: 7575
• Device Catalogue Number: 7575
• Device Lot Number: 0020958260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1