MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24696
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the severely calcified superficial femoral artery.A 4.0mm x 60mm x 150cm coyote balloon catheter was inflated repeatedly up to 14 atmospheres before the balloon ruptured.Another 4.0mm x 60mm x 150cm coyote balloon catheter was advanced; however, the second balloon also ruptured.Angiography was performed and the physician was satisfied with the result, and so the procedure was completed.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Returned product consisted of a coyote balloon catheter.The shafts, tip, and balloon were microscopically and visually examined.There was blood in the inflation lumen, guidewire lumen, and balloon.The balloon was loosely folded.Inspection of the device revealed that there was a 1.5cm longitudinal tear in the distal end of the balloon.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the severely calcified superficial femoral artery.A 4.0mm x 60mm x 150cm coyote balloon catheter was inflated repeatedly up to 14 atmospheres before the balloon ruptured.Another 4.0mm x 60mm x 150cm coyote balloon catheter was advanced; however, the second balloon also ruptured.Angiography was performed and the physician was satisfied with the result, and so the procedure was completed.There were no patient complications nor injuries reported.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9258346
• Report Number: 2134265-2019-13096
• Device Sequence Number: 2550679
• Product Code: LIT
• UDI-Device Identifier: 08714729796350
• UDI-Public: 08714729796350
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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 Model Number: 24696
• Device Catalogue Number: 24696
• Device Lot Number: 0024126659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR