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

Model Number 24691

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that removal difficulty was encountered.The stenosed target lesion was located in a forearm shunt.A 4mm x 20mm x 144cm coyote es balloon catheter was selected, during advancement there was difficultly tracking over the wire.During removal there was significant resistance was met between the guidewire and the coyote balloon catheter.They were able to remove the coyote balloon catheter and the wire remained inside the patient.When the coyote balloon catheter was checked outside the patient's body, the exit port was torn.The procedure was completed by dilating the lesion area with a different balloon catheter.No patient complications were reported.

Event Description

It was reported that removal difficulty was encountered.The stenosed target lesion was located in a forearm shunt.A 4mm x 20mm x 144cm coyote es balloon catheter was selected, during advancement there was difficultly tracking over the wire.During removal there was significant resistance was met between the guidewire and the coyote balloon catheter.They were able to remove the coyote balloon catheter and the wire remained inside the patient.When the coyote balloon catheter was checked outside the patient's body, the exit port was torn.The procedure was completed by dilating the lesion area with a different balloon catheter.No patient complications were reported.

Manufacturer Narrative

Age at time of event: 18 years or older.The returned complaint device consisted of a coyote es balloon catheter with an unidentified.014 guidewire in the device.The balloon is loosely folded.The hypotube, outer shaft, inner shaft, balloon and tip were visually and microscopically examined.There are numerous hypotube and shaft kinks.The wire was removed with little resistance but could not be reinserted and advanced due to the shaft kinks.The shaft is stretched in numerous locations.The shaft is damaged at the exit notch.The tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: COYOTE ES
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8569706
• MDR Text Key: 143721168
• Report Number: 2134265-2019-04712
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767299
• UDI-Public: 08714729767299
• Combination Product (y/n): N
• PMA/PMN Number: K093636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2022
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0023230208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1