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

Model Number	24704
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.During unpacking of a 2.0mm x 60mm x 150cm coyote balloon catheter, it was noted that it's end was broken.The device was not used inside the patient.No patient complications were reported.
Event or Problem Description
It was reported that a shaft break occurred.During unpacking of a 2.0mm x 60mm x 150cm coyote balloon catheter, it was noted that it's end was broken.The device was not used inside the patient.No patient complications were reported.Device evaluated by manufacturer: the returned product consisted of a coyote balloon catheter in one piece.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The shaft is kinked at the proximal balloon waist.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 event.
Additional Manufacturer Narrative
Initial reporter title updated from mr.To dr.Initial reporter first name updated from (b)(6) to (b)(6).Initial reporter last name updated from (b)(6) to (b)(6).Occupation updated from pharmacist to physician.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/14/2018 01:03 pm ct.The report number is being corrected from: 2134265-2018-64273 to: 2134265-2018-62921.

• 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: 8084772
• Report Number: 2134265-2018-62921
• Device Sequence Number: 1653417
• Product Code: DQY
• UDI-Device Identifier: 08714729796732
• UDI-Public: 08714729796732
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/22/2019

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: 05/06/2021
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0022083351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 11/23/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1