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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a rupture occurred.A 2.0mm x 220mm x 150cm coyote and a 4.0mm x 150mm x 150cm coyote were selected for use.During the procedure, the devices ruptured.There were no patient complications.
Event or Problem Description
It was reported that a rupture occurred.A 2.0mm x 220mm x 150cm coyote and a 4.0mm x 150mm x 150cm coyote were selected for use.During the procedure, the devices ruptured.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of a coyote balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a longitudinal tear 11.2cm from the tip and is approximately 48mm long.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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15486536
• Report Number: 2124215-2022-37702
• Device Sequence Number: 12083658
• Product Code: DQY
• UDI-Device Identifier: 08714729796664
• UDI-Public: 08714729796664
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2022

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: 03/10/2025
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0029026404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown