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

Model Number	7580
Medical Device Problem Codes	Inflation Problem (1310); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr.: returned product consisted of a maverick 2 balloon catheter.The hypotube was fractured 48cm from hub, the fractured ends were ovaled indicating that the hypotube was kinked prior to fracturing.There were numerous kinks throughout the hypotube.The balloon was inflated by connecting a toughy and stopcock to the fractured end and pressurizing with an inflation device.The balloon maintained pressure for 5 minutes and there were no leaks observed.
Event or Problem Description
Reportable based on device analysis completed on 30dec2019.It was reported that shaft kink and inflation failure occurred.Vascular access was obtained via femoral artery.The target lesion was located in the severely tortuous and mildly calcified left circumflex coronary artery.A 2.00mm x 12mm maverick balloon catheter was advanced for dilatation, but the shaft was kinked and the balloon could not inflate properly.The procedure was completed with a non-bsc balloon catheter.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed 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: 9590435
• Report Number: 2134265-2019-16796
• Device Sequence Number: 3012446
• 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): 01/15/2020

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: 06/11/2022
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0023938972
• 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: 12/30/2019
• Initial Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1