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

Model Number	24705
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of a coyote es balloon catheter with an unknown 0.014 inch guidewire stuck inside the device.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed buckling to the guidewire lumen 5mm from the tip.The balloon was found separated 13.5cm from the tip.The entire guidewire lumen appears to be stretched.Microscopic examination revealed no additional damages.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that the balloon had a leak.A coyote 2.0mm x 120mm x 150cm balloon catheter was selected for use to treat bruton's tyrosine kinase.The physician inserted the catheter, and upon treatment there was a balloon leak.The procedure was able to be completed successfully using a new balloon without sequela.However, device analysis revealed the balloon was separated.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13942632
• Report Number: 2134265-2022-03213
• Device Sequence Number: 11881215
• Product Code: DQY
• UDI-Device Identifier: 08714729797159
• UDI-Public: 08714729797159
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2022

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: 08/05/2024
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0027790610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown