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

Model Number	24701
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2018
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 anterior tibial artery.A 2.5mm x 40mm x 145cm coyote es balloon catheter was advanced for dilation; however, upon inflation the balloon ruptured due to calcification.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the severely calcified anterior tibial artery.A 2.5mm x 40mm x 145cm coyote es balloon catheter was advanced for dilation, however, upon inflation the balloon ruptured due to calcification.The procedure was completed with a different device.No patient complications were reported and the patients status was stable.Device evaluated by mfr: returned product consisted of a coyote es balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast inflation lumen and balloon.The balloon was loosely folded.There was a 1.5cm longitudinal tear in the balloon starting at the proximal end of the balloon.Inspection of the device presented no other damage or irregularities.

• Brand Name: COYOTE ES
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7803436
• Report Number: 2134265-2018-60316
• Device Sequence Number: 1852503
• Product Code: LIT
• UDI-Device Identifier: 08714729767381
• UDI-Public: 08714729767381
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K093636
• 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): 10/16/2018

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: 06/27/2019
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0020820829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR