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	11/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in a vessel below the knee.A 300cm straight tip v-14 control wire was advanced to cross the lesion.However, it was noted that the wire tip was torn apart from the wire body and need to use a snare to remove it out.It was also found that the wire became stuck in the 2.5mm x 80mm x 150cm coyote balloon catheter.The procedure was completed with another of same device.There were no patient complications reported and the patient condition was stable.
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in a vessel below the knee.A 300cm straight tip v-14 control wire was advanced to cross the lesion.However, it was noted that the wire tip was torn apart from the wire body and need to use a snare to remove it out.It was also found that the wire became stuck in the 2.5mm x 80mm x 150cm coyote balloon catheter.The procedure was completed with another of same device.There were no patient complications reported and the patient condition was stable.
Additional Manufacturer Narrative
A2.Age at time of event: 18 years or older.Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter with a 0.014 inch guidewire stuck inside.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed that the tip is damaged/torn from the distal end to 5mm from the tip.There is multiple buckling to the guidewire lumen.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; 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: 12887104
• Report Number: 2134265-2021-14635
• Device Sequence Number: 3900372
• Product Code: DQY
• UDI-Device Identifier: 08714729797180
• UDI-Public: 08714729797180
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 02/21/2022

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: 04/11/2024
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0027124488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• 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 Sex: Unknown