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

Model Number	24706
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that balloon rupture occurred.A 3.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilation.However, during inflation at minimial inflation, the balloon ruptured.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
B3: date of event: updated to (b)(6) 2021.
Event or Problem Description
It was reported that balloon rupture occurred.A 3.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilation.However, during inflation at minimal inflation, the balloon ruptured.The procedure was completed with a different device.There were no patient complications nor injuries reported.It was further reported that the target lesion was located in the mildly tortuous and very calcified distal popliteal into post tibial artery.

• 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: 11419021
• Report Number: 2134265-2021-02834
• Device Sequence Number: 2775612
• Product Code: DQY
• UDI-Device Identifier: 08714729797265
• UDI-Public: 08714729797265
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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: 12/10/2023
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0026495216
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR