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

Model Number	24704
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.The target lesion was located in a vessel of the lower leg.A 014/300/sst platinum plus - pi guidewire was advanced.A 3.0mm x 60mm x 150cm, otw coyote balloon catheter was advanced for dilation.At some point during the procedure, the tip of the 014/300/sst platinum plus - pi guidewire unraveled.While attempting to remove the 3.0mm x 60mm x 150cm, otw coyote balloon catheter at the end of the procedure, the coyote balloon catheter and platinum plus pi guidewire could not be separated and were removed together from the patient.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that removal difficulties were encountered.The target lesion was located in a vessel of the lower leg.A 014/300/sst platinum plus - pi guidewire was advanced.A 3.0mm x 60mm x 150cm, otw coyote balloon catheter was advanced for dilation.At some point during the procedure, the tip of the 014/300/sst platinum plus - pi guidewire unraveled.While attempting to remove the 3.0mm x 60mm x 150cm, otw coyote balloon catheter at the end of the procedure, the coyote balloon catheter and platinum plus pi guidewire could not be separated and were removed together from the patient.There were no patient complications nor injuries reported.It was further reported that the target lesion was 100% stenosed, severely calcified, and non-tortuous.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a coyote balloon with the batch number of 26087972 located on the device hub.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no visible damage.Further microscopic inspection of the device found a buckled guidewire lumen, inside of the device manifold.Guidewire insertion test failed when attempted to insert into the buckled portion of the lumen.The balloon was inflated and contained blood, 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.
Event or Problem Description
It was reported that removal difficulties were encountered.The target lesion was located in a vessel of the lower leg.A 014/300/sst platinum plus - pi guidewire was advanced.A 3.0mm x 60mm x 150cm, otw coyote balloon catheter was advanced for dilation.At some point during the procedure, the tip of the 014/300/sst platinum plus - pi guidewire unraveled.While attempting to remove the 3.0mm x 60mm x 150cm, otw coyote balloon catheter at the end of the procedure, the coyote balloon catheter and platinum plus pi guidewire could not be separated and were removed together from the patient.There were no patient complications nor injuries reported.It was further reported that the target lesion was 100% stenosed, severely calcified, and non-tortuous.

• 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: 12771731
• Report Number: 2134265-2021-13896
• Device Sequence Number: 11549635
• Product Code: DQY
• UDI-Device Identifier: 08714729797227
• UDI-Public: 08714729797227
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2022

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: 09/28/2023
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0026087972
• 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): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 11/04/2021; 12/16/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 11/18/2021; 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2020
• 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 Sex: Unknown