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	09/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in a shunt in the moderately tortuous and mildly calcified left forearm.A 2.5mm x 20mm x 143cm coyote balloon catheter was advanced for dilation.However, on initial inflation at 4 atmospheres for 5 seconds, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in a shunt in the moderately tortuous and mildly calcified left forearm.A 2.5mm x 20mm x 143cm coyote balloon catheter was advanced for dilation.However, on initial inflation at 4 atmospheres for 5 seconds, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported.Returned product consisted of a coyote es balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the device.Microscopic examination revealed a longitudinal tear in the balloon 7mm from the tip and approximately 18mm long.The tip is damaged and the balloon is loosely folded.There is blood present in the guidewire lumen, inflation lumen, and balloon.The reported information indicates the device was inflated to 4 atm; therefore, there is no indication the device was inflated over rbp.Inspection of the remainder 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: 7987508
• Report Number: 2134265-2018-62142
• Device Sequence Number: 11121185
• Product Code: LIT
• UDI-Device Identifier: 08714729767367
• UDI-Public: 08714729767367
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/13/2018

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: 12/19/2019
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0021533859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1