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

Model Number	24706
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the heavily calcified anterior tibial artery.A 2.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.However, during the initial inflation at 14 atmospheres, the balloon ruptured.The device was removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the heavily calcified anterior tibial artery.A 2.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.However, during the initial inflation at 14 atmospheres, the balloon ruptured.The device was removed from the patient's body and the procedure was completed with another of same device.No patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned device consisted of a coyote otw balloon catheter.The balloon was loosely folded, and the device was bloody.Analysis of the tip, balloon, markerband, inner / outer shaft, hypotube and hub included microscopic and visual inspection.Inspection revealed a pinhole in the balloon material that was located 32mm from the tip of the device.Inspection of the device found no other damage or defects.

• 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: 10221834
• Report Number: 2134265-2020-08828
• Device Sequence Number: 11580928
• Product Code: DQY
• UDI-Device Identifier: 08714729796466
• UDI-Public: 08714729796466
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 08/18/2020

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: 09/11/2022
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0024417675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR