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

Model Number	7580
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2020
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 circumflex artery.A 2.50mm x 12mm maverick balloon catheter was advanced for dilation, but failed to cross the lesion due to severe calcification.The balloon was inflated; however, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was good.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the severely calcified left circumflex artery.A 2.50mm x 12mm maverick balloon catheter was advanced for dilation, but failed to cross the lesion due to severe calcification.The balloon was inflated; however, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was good.
Additional Manufacturer Narrative
Device evaluated by mfr.: the returned complaint device consisted of a maverick 2 balloon catheter.The balloon is loosely folded.The hypotube, outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Microscopic examination revealed that there is a hole in the balloon at the distal markerband.The tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that could have contributed to the reported event.

• 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: 10112970
• Report Number: 2134265-2020-07425
• Device Sequence Number: 19695032
• Product Code: LOX
• UDI-Device Identifier: 08714729369981
• UDI-Public: 08714729369981
• 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): 07/30/2020

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: 11/24/2022
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0024830298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR