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

Model Number	24705
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 2.0mm x 150mm x 150cm coyote balloon catheter was selected for use.However, during preparation/prior to sedation, it was noted that there was a fracture on the catheter of the balloon so it was unusable.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a coyote balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that shaft break occurred.A 2.0mm x 150mm x 150cm coyote balloon catheter was selected for use.However, during preparation/prior to sedation, it was noted that there was a fracture on the catheter of the balloon so it was unusable.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.

• 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: 10240128
• Report Number: 2134265-2020-08238
• Device Sequence Number: 2433237
• Product Code: DQY
• UDI-Device Identifier: 08714729796459
• UDI-Public: 08714729796459
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

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: 09/03/2022
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0024371958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1