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

Model Number	24704
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon was entrapped on the guidewire.The 80% target lesion was located in the moderately to severely tortuous and severely calcified vessel in the lower leg.A 3.0mm x 60mm x 90cm coyote balloon catheter was advanced for dilatation.During device removal, difficulties were encountered with the 0.014 non-boston scientific guidewire.They tried multiple ways to retrieve the device and had both devices removed together.It was then noted that the yellow end tip came off and went missing.No complications were reported.
Event or Problem Description
It was reported that the balloon was entrapped on the guidewire.The 80% target lesion was located in the moderately to severely tortuous and severely calcified vessel in the lower leg.A 3.0mm x 60mm x 90cm coyote balloon catheter was advanced for dilatation.During device removal, difficulties were encountered with the 0.014 non-boston scientific guidewire.They tried multiple ways to retrieve the device and had both devices removed together.It was then noted that the yellow end tip came off and went missing.No complications were reported.It was further reported that the yellow end tip of the balloon has fallen off and was left inside the patient due to the high degree of stenosis and calcification of the anatomy and only discovered missing upon removal.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the balloon is separated 93.5cm from the hub.The guidewire lumen is separated in two pieces and stuck on the returned guidewire.A piece measures approximately 3.3cm and the other piece measures approximately 124.2cm long.There is multiple buckling to the guidewire lumen.Microscopic examination revealed no additional damages.The distal section of the separated balloon, one marker band, part of the guidewire lumen, and the tip did not return for analysis.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; 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: 18924471
• Report Number: 2124215-2024-16060
• Device Sequence Number: 18503101
• Product Code: DQY
• UDI-Device Identifier: 08714729797234
• UDI-Public: 08714729797234
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2026
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0030825075
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: 0.014 ADVANTAGE; GUIDEWIRE: 0.014 ADVANTAGE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown