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

Model Number	7580
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr.:returned product consisted of a maverick 2 balloon catheter.There were numerous kinks throughout the device.The hypotube was separated 15cm from hub, the ends were ovaled which is consistent with kinking prior to separation.The balloon was inflated by connecting a toughy, stopcock, and inflation device to the separated end.Pressure was applied to the balloon and the balloon remained inflated.
Event or Problem Description
Reportable based on device analysis completed on 03-jan-2020.It was reported that inflation failure occurred.Vascular access was obtained via femoral artery.The target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.00mm x 12mm maverick balloon catheter was advanced for pre-dilation.However, during procedure, the balloon failed to inflate.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.However, device analysis revealed a shaft 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: 9617200
• Report Number: 2134265-2020-00197
• Device Sequence Number: 13599539
• Product Code: LOX
• UDI-Device Identifier: 08714729369967
• UDI-Public: 08714729369967
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 01/22/2020

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: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0022701216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1