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

Model Number	24701
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that deflation failure occurred.The 60-70% stenosed target lesion was located in the non-calcified vessel of the lower extremity.A 3mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.The device had difficulty advancing over the wire upon introduction into the vessel.The device was removed, and the wire port was flushed.The balloon was re-introduced and was able to cross the lesion.The balloon was inflated at 14 atmospheres for 2 minutes.The device was then deflated, however, it failed to deflate despite multiple attempts to apply negative pressure with both a balloon inflator device and a large syringe.The physician retracted the balloon through the vessels and the sheath while it was still inflated.The balloon encountered significant resistance at the sheath but was able to be removed.Upon removal, the balloon seemed to be inverted on itself, most likely due to the force of pulling it through the sheath while still inflated.The patient did not experience any symptoms, and there was no complications or further intervention required.The patient condition was good.

• Brand Name: COYOTE ES
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11634479
• Report Number: 2134265-2021-04461
• Device Sequence Number: 3547221
• Product Code: LIT
• UDI-Device Identifier: 08714729767398
• UDI-Public: 08714729767398
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K093636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2021

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 Expiration Date: 10/06/2022
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0026135091
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2021
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention