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

Model Number	24691
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the internal carotid artery.After a non-bsc guidewire crossed the lesion, a 2.5mm x 30mm x 145cm coyote es balloon catheter was advanced for dilatation.However, during advancement of the device, slight resistance was felt.After dilatation was performed, the balloon could not be removed from the guide catheter with the guide wire being remained inside the body.The balloon catheter and the guide wire were then removed together outside the patient's body.When tried to removed the balloon from the guide wire, severe resistance was felt but eventually the balloon catheter was able to remove.Finally, after placing the same guide wire in the lesion, an 8mm x 29mm carotid wall stent advanced and completed the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Initial reporter city: (b)(6).Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.The inner shaft was stretched down starting at 8cm from the tip and the inner shaft in the balloon was buckled at the distal end of the balloon.A functional test was done with a 0.014" guidewire.The guidewire was unable to get past the inner shaft damage when inserted from the exit notch and was unable to enter through the tip.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the internal carotid artery.After a non-bsc guidewire crossed the lesion, a 2.5mm x 30mm x 145cm coyote es balloon catheter was advanced for dilatation.However, during advancement of the device, slight resistance was felt.After dilatation was performed, the balloon could not be removed from the guide catheter with the guide wire being remained inside the body.The balloon catheter and the guide wire were then removed together outside the patient's body.When tried to removed the balloon from the guide wire, severe resistance was felt but eventually the balloon catheter was able to remove.Finally, after placing the same guide wire in the lesion, an 8mm x 29mm carotid wall stent advanced and completed the procedure.No patient complications were reported.

• 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: 8781026
• Report Number: 2134265-2019-07559
• Device Sequence Number: 2639170
• Product Code: LIT
• UDI-Device Identifier: 08714729767213
• UDI-Public: 08714729767213
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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: 11/11/2021
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0022924052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1