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

Model Number	24701
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
Reportable based on device analysis completed on 02-oct-2018.It was reported that balloon inflation failure occurred.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified superficial femoral artery.After a guide wire was crossed, a 2.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilation.However, the device failed to inflate.It was pulled out from the sheath as it was.The physician said that the inflation lumen and the wire lumen were connected.The procedure was completed with a different device.No patient complications were reported.However, returned device analysis revealed a pinhole in the guide wire lumen.Device evaluated by mfr: returned product consisted of a coyote es balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination did not reveal any damages.Microscopic examination revealed that the tip is damaged and there is a pinhole in the guidewire lumen 2.6 cm from the tip.There is blood present in the guidewire lumen and the balloon is loose.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: 7999495
• Report Number: 2134265-2018-61872
• Device Sequence Number: 202781
• 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
• Report Date (Section B): 10/24/2018

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: 11/17/2019
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0021402580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: CRUISE; INTRODUCER SHEATH: PARENT 4.5F