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

Model Number	24706
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified below-the-knee vessel.A 2.5mm x 220mm x 150cm coyote balloon catheter was advanced over a 300cm straight tip v-14 control wire guidewire.However, during introduction, resistance was felt and it was evident that the balloon catheter had gotten stuck with the guidewire.Furthermore, it was noted that tip of the guidewire was kinked.Both devices were removed together as one unit and the lesion was re-accessed with new devices.The procedure was completed and no patient complications were reported.
Event or Problem Description
It was reported that device entrapment occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified below-the-knee vessel.A 2.5mm x 220mm x 150cm coyote balloon catheter was advanced over a 300cm straight tip v-14 control wire guidewire.However, during introduction, resistance was felt and it was evident that the balloon catheter had gotten stuck with the guidewire.Furthermore, it was noted that tip of the guidewire was kinked.Both devices were removed together as one unit and the lesion was re-accessed with new devices.The procedure was completed and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a coyote balloon.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a buckled guidewire lumen at 18.3cm from the tip, as well as 22.5cm-16cm from the tip.Microscopic examination revealed no further damage.Guidewire insertion test failed when attempted to insert into the buckled portion of the lumen.The balloon was unraveled and traces of contrast fluid were found, indicating the device had been used.Inspection of the remainder of the device showed no signs of additional damage to the device.Product analysis confirmed the allegations of guidewire loading failures.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12711465
• Report Number: 2134265-2021-13143
• Device Sequence Number: 20009487
• Product Code: DQY
• UDI-Device Identifier: 08714729796718
• UDI-Public: 08714729796718
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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: 05/12/2024
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0027302802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2021
• 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: 79 YR
• Patient Sex: Female