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

Model Number	24705
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon detachment occurred.A 3.0mm x 120mm x 150cm coyote balloon catheter was selected for use; however, when the device was removed from the sterile packaging, it was noted that the balloon material was broken.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a coyote balloon catheter with an unidentified guidwire in the lumen.The balloon is loosely folded with blood in the guidewire lumen.Although it was reported that the device was not used, the presence of blood in the guidewire lumen is indicative of handling beyond simply unpackaging the device, as was reported.The outer shaft, inner shaft, balloon and tip were microscopically examined.The shaft is severely buckled in numerous locations.There are numerous shaft kinks.The tip is damaged.The device was soaked in a water bath for 4 days and the guidewire was unable to be removed from the catheter due to the severe buckling.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon detachment occurred.A 3.0mm x 120mm x 150cm coyote balloon catheter was selected for use; however, when the device was removed from the sterile packaging, it was noted that the balloon material was broken.The procedure was completed with a different device.No patient complications were reported.

• 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: 8121293
• Report Number: 2134265-2018-63361
• Device Sequence Number: 234006
• Product Code: DQY
• UDI-Device Identifier: 08714729796725
• UDI-Public: 08714729796725
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 01/15/2019

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: 12/03/2020
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0021465307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1