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

Model Number	24698
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was resistance encountered when advancing and retracting the device.A coyote balloon was selected for use in the percutaneous transluminal angioplasty procedure.The target lesion was located in the crural vessels and was 70% stenosed with mild tortuosity and moderate calcification.The coyote was advanced over a v-14 controlwire, but just before the coyote was about to enter the patient, there was resistance encountered.The balloon became stuck on the guidewire.Force was required to withdraw the balloon from the guidewire.The wire remained in the patient, and the coyote balloon was replaced with another of the same size to complete the procedure.There was no resistance encountered when advancing or retracting the second coyote balloon over the original v-14.The procedure was completed and there were no reported patient complications.
Event or Problem Description
It was reported that there was resistance encountered when advancing and retracting the device.A coyote balloon was selected for use in the percutaneous transluminal angioplasty procedure.The target lesion was located in the crural vessels and was 70% stenosed with mild tortuosity and moderate calcification.The coyote was advanced over a v-14 controlwire, but just before the coyote was about to enter the patient, there was resistance encountered.The balloon became stuck on the guidewire.Force was required to withdraw the balloon from the guidewire.The wire remained in the patient, and the coyote balloon was replaced with another of the same size to complete the procedure.There was no resistance encountered when advancing or retracting the second coyote balloon over the original v-14.The procedure was completed and there were no reported patient complications.
Additional Manufacturer Narrative
Device analysis: returned product consisted of a coyote balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination revealed buckling to the guidewire lumen 4mm from the tip.The guidewire lumen was separated 39.5cm from the tip.The inflation lumen was separated 41.6cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that would have contributed to the difficulty to track over wire and difficulty to remove.

• 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: 18954814
• Report Number: 2124215-2024-16221
• Device Sequence Number: 21193636
• Product Code: LIT
• UDI-Device Identifier: 08714729796947
• UDI-Public: 08714729796947
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 04/23/2024

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: 05/14/2026
• Device Model Number: 24698
• Device Catalogue Number: 24698
• Device Lot Number: 0031616181
• 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: 03/07/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: V-14 CONTROLWIRE; V-14 CONTROLWIRE
• Patient Sex: Unknown