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

Model Number	24705
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous poplitial artery.A 4.0mm x 150mm x 150cm coyote balloon catheter was advanced for pre-dilatation.However, during second inflation the balloon ruptured.The device was completely removed from the patient and the procedure was completed with a 4mm peripheral cutting balloon.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous popliteal artery.A 4.0mm x 150mm x 150cm coyote balloon catheter was advanced for pre-dilatation.However, during second inflation the balloon ruptured.The device was completely removed from the patient and the procedure was completed with a 4mm peripheral cutting balloon.No patient complications were reported.Returned product consisted of a coyote balloon catheter.The balloon is loosely folded with blood in the inflation lumen and balloon.The outer shaft, inner shaft, balloon and tip were microscopically examined.Microscopic examination revealed that the balloon has a 27mm longitudinal tear starting 51mm from the proximal markerband.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported event.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.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 12/19/2018 04:47 pm ct.The report number is being corrected from: 2134265-2018-64383 to: 2134265-2018-63124.

• 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: 8098950
• Report Number: 2134265-2018-63124
• Device Sequence Number: 2165147
• Product Code: DQY
• UDI-Device Identifier: 08714729796664
• UDI-Public: 08714729796664
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• 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: 05/03/2021
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0022077537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 11/22/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INFLATION DEVICE: ENCORE 26; INFLATION DEVICE: ENCORE 26