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

Model Number	24705
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that difficulty removing a balloon occurred.A limb salvage case was performed on a calcified vessel.A 2.00mm x 120mm x 150cm coyote balloon and a v-14 control wire were delivered through a 4fr sheath through the calcified vessel.The wire and the balloon became stuck at the dorsalis pedis and excessive force had to be used to remove the balloon and the wire, which had become stuck together.It was noted that there was no harm to the patient, but the operator had intended to progress treatment further into the plantar arch.The case was abandoned and no further products were used.No patient complications resulted in relation to this event.
Additional Manufacturer Narrative
The returned product consisted of a coyote balloon catheter with the guide wire stuck in the device.There was 23mm of wire protruding out form the device tip, and 142.5cm of wire coming out from the hub of the device.The devices could not be separated during analysis.Microscopic and visual inspection revealed tip damage (smashed/compressed) and balloon/ damage (buckled) for approximately 10.6cm in length.Inspection of the rest of the device found no other damage or defect.The reported difficulty withdrawing the balloon was confirmed.
Event or Problem Description
It was reported that difficulty removing a balloon occurred.A limb salvage case was performed on a calcified vessel.A 2.00mm x 120mm x 150cm coyote balloon and a v-14 control wire were delivered through a 4fr sheath through the calcified vessel.The wire and the balloon became stuck at the dorsalis pedis and excessive force had to be used to remove the balloon and the wire, which had become stuck together.It was noted that there was no harm to the patient, but the operator had intended to progress treatment further into the plantar arch.The case was abandoned and no further products were used.No patient complications resulted in relation to this event.

• 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: 10969082
• Report Number: 2134265-2020-17114
• Device Sequence Number: 4168817
• Product Code: DQY
• UDI-Device Identifier: 08714729797159
• UDI-Public: 08714729797159
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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: 06/08/2023
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0025570340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1