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

Model Number	7605
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the severely calcified left anterior descending artery.A 2.00mm x 30mm maverick 2 balloon catheter was advanced for dilatation.However, during inflation at nominal pressure, the balloon ruptured.The device was completely removed and the procedure was completed with another of the same device.No patient serious injury or adverse event were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of the maverick 2 balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.The device had numerous kinks throughout the hypotube.There was contrast and blood in the inflation lumen and balloon.The balloon was loosely folded but appeared twisted at the time of inspection.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.The device would not inflate due to the dried contrast and blood.The device was soaked in a water bath for four days to loosen the contrast material and blood to inspect and inflate the balloon.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device again to the rated burst pressure.There was a stream of water emitting from the distal end of the balloon.Microscopic inspection of the device revealed a pinhole in the balloon at the proximal end of the distal marker band and tip damage.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the severely calcified left anterior descending artery.A 2.00mm x 30mm maverick 2 balloon catheter was advanced for dilatation.However, during inflation at nominal pressure, the balloon ruptured.The device was completely removed and the procedure was completed with another of the same device.No patient serious injury or adverse event were reported.

• 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: 8516600
• Report Number: 2134265-2019-03906
• Device Sequence Number: 2758929
• Product Code: LOX
• UDI-Device Identifier: 08714729370345
• UDI-Public: 08714729370345
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 05/07/2019

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: 12/12/2021
• Device Model Number: 7605
• Device Catalogue Number: 7605
• Device Lot Number: 0023077288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR