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

Model Number	24704
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event date was note reported.The first date of the month of the aware date was entered as an estimate.
Event or Problem Description
It was reported that balloon deflation issues occurred.The target lesion was located in the tibial artery.This 3.0mm x 60mm x 90cm coyote balloon catheter was advanced to the target lesion and inflated.However, the balloon would not deflate and had do be withdrawn from the patient inflated.
Additional Manufacturer Narrative
B3: event date: the event date was note reported.The first date of the month of the aware date was entered as an estimate.Dev returned to manufacturer: the returned product consisted of a coyote balloon catheter.The balloon was loosely folded with solid contrast in the balloon and shaft, and the device was bloody.The device was soaked in a warm water bath for three days.Analysis of the tip, balloon, inner/outer shaft and hypotube included microscopic and visual inspection.Inspection revealed tip damage, and a perforation in the inner shaft that was located 7.1cm from the tip of the device.Inspection of the rest of the device found no other damage or defect.The device was functionally tested by attaching an inflation device (filled with water) to the hub of the balloon catheter and applying positive pressure.The balloon was inflated, but could not hold any pressure, and the balloon could not be inflated.Because the balloon could not inflate, the difficulty deflating could not be replicated.
Event or Problem Description
It was reported that balloon deflation issues occurred.The target lesion was located in the tibial artery.This 3.0mm x 60mm x 90cm coyote balloon catheter was advanced to the target lesion and inflated.However, the balloon would not deflate and had do be withdrawn from the patient inflated.

• 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: 9699453
• Report Number: 2134265-2020-01342
• Device Sequence Number: 19302068
• Product Code: DQY
• UDI-Device Identifier: 08714729797234
• UDI-Public: 08714729797234
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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: 08/13/2022
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0024263623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/11/2020
• Patient Sequence Number: 1