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

Model Number	24704
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon hole occurred.During preparation of a 1.5mm x 40mm x 150cm coyote balloon catheter, it was noted that the balloon had a small hole in it and was not used in the case.The procedure was completed with a another coyote balloon catheter.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned complaint device consisted of a coyote balloon catheter.The balloon was loosely folded with blood in the balloon and lumen.Although it was reported that the device was not used, the presence of blood and contrast media 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.Microscopic examination revealed that there was a hole in the shaft 1mm proximal of the proximal balloon waist.The tip was damaged.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon hole occurred.During preparation of a 1.5mm x 40mm x 150cm coyote balloon catheter, it was noted that the balloon had a small hole in it and was not used in the case.The procedure was completed with a another coyote balloon catheter.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: 10246443
• Report Number: 2134265-2020-08232
• Device Sequence Number: 536467
• Product Code: DQY
• UDI-Device Identifier: 08714729796411
• UDI-Public: 08714729796411
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 02/09/2023
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0025181616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 07/26/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1