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

Model Number	24704
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned complaint device consisted of a coyote balloon catheter.The balloon is loosely folded with blood in the balloon.The hypotube, outer shaft, inner shaft, balloon and tip were visually and microscopically examined.The tip is damaged.Leak testing was performed by connecting the balloon catheter to an inflation device full of water.When the positive pressure was applied, the device leaked water from the proximal balloon weld area.Microscopic examination revealed that there is a scraping mark and a puncture hole in the shaft that is causing the leak at the proximal balloon weld.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported difficult.
Event or Problem Description
Reportable based on the device analysis completed on 05apr2019.It was reported that crossing difficulties were encountered.The 80% stenosed target lesion was located in the severely tortuous and moderately calcified posterior tibial artery.A 1.5mm x 40mm x 150cm coyote balloon catheter was advanced but failed to cross the lesion.The procedure was completed with a different device.No patient complications were reported.However, returned device analysis revealed a shaft puncture hole.

• 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: 8560992
• Report Number: 2134265-2019-04499
• Device Sequence Number: 1852178
• Product Code: DQY
• UDI-Device Identifier: 08714729796411
• UDI-Public: 08714729796411
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2019

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: 09/19/2021
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 22680015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR