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

Model Number	7575
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	07/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the complexly tortuous and moderately calcified coronary artery.A 2.00mm x 9mm maverick balloon catheter was advanced for dilatation but resistance was encountered.The device was completely removed and it was noted that the distal segment of the catheter was kinked.The procedure was completed using a maverick balloon catheter with a smaller diameter.However, while manipulating the balloon for decontamination, the catheter broke and the portions that were originally bent were separated.No patient complications were reported and the patient's status was okay.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the complexly tortuous and moderately calcified coronary artery.A 2.00mm x 9mm maverick balloon catheter was advanced for dilatation but resistance was encountered.The device was completely removed and it was noted that the distal segment of the catheter was kinked.The procedure was completed using a maverick balloon catheter with a smaller diameter.However, while manipulating the balloon for decontamination, the catheter broke and the portions that were originally bent were separated.No patient complications were reported and the patient's status was okay.It was additionally reported that vascular access was obtained via the radial artery and that the 10x3.0mm, de novo, eccentric target lesion was located in a severely tortuous and moderately calcified left anterior descending artery.Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter in two pieces.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The shaft was completely separated/torn 118.5cm from the hub.The fractured/separated ends of the distal shaft are stretched and jagged which indicates the shaft separation was due to tensile forces.There are numerous hypotube kinks.The exit notch is torn/damaged.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 7813759
• Report Number: 2134265-2018-60426
• Device Sequence Number: 11176004
• Product Code: LOX
• UDI-Device Identifier: 08714729369875
• UDI-Public: 08714729369875
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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,Followup
• Report Date (Section B): 09/21/2018

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: 10/25/2020
• Device Model Number: 7575
• Device Catalogue Number: 7575
• Device Lot Number: 0021304075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR