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

Model Number	24704
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that a froze on wire occurred.The 70% stenosed target lesion was located in the anterior tibial artery.A 2.5mm x 100mm x 150cm coyote balloon catheter was advanced for dilation.However, the balloon and a non bsc guidewire was stuck firmly inside the patient's body and cannot be withdrawn.Both devices were removed together.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that a froze on wire occurred.The 70% stenosed target lesion was located in the anterior tibial artery.A 2.5mm x 100mm x 150cm coyote balloon catheter was advanced for dilation.However, the balloon and a non bsc guidewire was stuck firmly inside the patient's body and cannot be withdrawn.Both devices were removed together.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Returned product consisted of a coyote balloon catheter with an unidentified guide wire in the lumen.The balloon is loosely folded.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.The tip is damaged.The unidentified wire was measured to be a 0.014 inch guidewire.The inner shaft is buckled under the manifold and strain relief preventing the wire from moving.The device was soaked in a warm water batch for 1 week.The wire was able to be removed after being soaked with little restriction due to the buckled shaft.The tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 8449908
• Report Number: 2134265-2019-02927
• Device Sequence Number: 3057496
• Product Code: DQY
• UDI-Device Identifier: 08714729796503
• UDI-Public: 08714729796503
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/17/2019

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: 08/31/2019
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0019596564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 05/17/2019
• 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: GUIDEWIRE: ABBOT; GUIDEWIRE: ABBOT
• Patient Age: 50 YR
• Patient Weight: 80