MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE?; CATHETER, PERCUTANEOUS

Model Number	H74939185202210
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: pro code (product code): dqy, lit.G4: premarket / 510(k) #: k103751, k110122.
Event or Problem Description
It was reported that froze on wire occurred and additional intervention was performed.The 100% stenosed target lesion was located in the moderately calcified anterior tibial artery.A 2.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilation.The procedure identified residual stenosis, prompting a post-dilatation with a plain old balloon angioplasty (poba) at the mid-section.Following the poba, an attempt was made to withdraw the balloon catheter; however, it became lodged along with the jupiter fc guidewire.Further efforts to advance the guidewire distally were unsuccessful, as it remained firmly entrapped.At this point, it is likely that significant damage occurred to the guidewire while it was still within the patient.Due to the challenges encountered with the ipsilateral approach, the procedure was transitioned to a contralateral approach.The balloon catheter was intentionally ruptured at the hub to facilitate removal.Using a snare, the integrated balloon catheter and guidewire were successfully retrieved.The procedure was subsequently completed using a different device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that froze on wire occurred and additional intervention was performed.The 100% stenosed target lesion was located in the moderately calcified anterior tibial artery.A 2.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilation.The procedure identified residual stenosis, prompting a post-dilatation with a plain old balloon angioplasty (poba) at the mid-section.Following the poba, an attempt was made to withdraw the balloon catheter; however, it became lodged along with the jupiter fc guidewire.Further efforts to advance the guidewire distally were unsuccessful, as it remained firmly entrapped.At this point, it is likely that significant damage occurred to the guidewire while it was still within the patient.Due to the challenges encountered with the ipsilateral approach, the procedure was transitioned to a contralateral approach.The balloon catheter was intentionally ruptured at the hub to facilitate removal.Using a snare, the integrated balloon catheter and guidewire were successfully retrieved.The procedure was subsequently completed using a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b: pro code (product code): dqy, lit reported here as the pro code exceeded the character limit for designated field g4: premarket / 510(k): k103751, k110122 reported here as the pma/510k exceeded character limit for designated field device evaluated by mfr: the coyote was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the inflation lumen is separated 71.3cm from the hub and the core wire is kinked at the separation.Microscopic examination revealed no additional damages.The markerband, balloon, tip, and distal section of the shaft are all missing.Product analysis found damage to the device that would have contributed to the reported event.

• Brand Name: COYOTE?
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 22792414
• Report Number: 2124215-2025-55495
• Device Sequence Number: 18208881
• Product Code: DQY
• UDI-Device Identifier: 08714729796817
• UDI-Public: (01)08714729796817(17)280316(10)36080161
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/11/2025

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 Model Number: H74939185202210
• Device Catalogue Number: H74939185202210
• Device Lot Number: 0036080161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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: INTRODUCER SHEATH - MEDIKIT PARENT SELECT 5082.; INTRODUCER SHEATH - MEDIKIT PARENT SELECT 5082.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown