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

Model Number	24698
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.During unpacking of a 2.5mm x 150mm x 150cm coyote balloon catheter, it was observed that the balloon was fractured.The procedure was completed another of the same device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that shaft break occurred.During unpacking of a 2.5mm x 150mm x 150cm coyote balloon catheter, it was observed that the balloon was fractured.The procedure was completed another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that the shaft was kinked at 135cm from the hub and was not broken as what previously reported.
Additional Manufacturer Narrative
Updated b5: describe event or problem: corrected h6: device code from break to material deformation.E1: initial reporter phone: (b)(6).

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17862638
• Report Number: 2124215-2023-54466
• Device Sequence Number: 17565908
• Product Code: LIT
• UDI-Device Identifier: 08714729796886
• UDI-Public: 08714729796886
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

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: 07/11/2025
• Device Model Number: 24698
• Device Catalogue Number: 24698
• Device Lot Number: 0029745360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 70 KG