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

Model Number	7575
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter with the balloon protector and product mandrel still in the manufactured position.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a kink on the hypotube 92cm from the hub.There is a kink to the inflation lumen and core wire 23.9cm from the tip.Microscopic examination revealed a longitudinal tear in the balloon 4mm from the tip and approximately 10.5mm long.The tip is damaged and there in contrast present in the inflation lumen.The balloon is loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2019.It was reported that crossing difficulties were encountered.Vascular access was obtained via the femoral artery.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.A 2.00mm x 9mm maverick balloon catheter was advanced for dilation; however, the device failed to cross due to calcification.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.However, returned device analysis revealed balloon longitudinal tear.

• 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: 8388034
• Report Number: 2134265-2019-01997
• Device Sequence Number: 13965819
• Product Code: LOX
• UDI-Device Identifier: 08714729369875
• UDI-Public: 08714729369875
• 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): 03/04/2019

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: 02/22/2021
• Device Model Number: 7575
• Device Catalogue Number: 7575
• Device Lot Number: 0021781743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1