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

Model Number 24701

Device Problems Entrapment of Device (1212); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2022

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: (b)(6) or older.(b)(6).

Event Description

It was reported that device entrapment occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified below-the-knee vessel.A 1.5mm x 20mm x 142cm coyote es balloon catheter was advanced for dilatation.During guidewire exchange, a 235cm jupiter fc3 guidewire was removed without resistance and was replaced with a 300cm jupiter fc guidewire.However, during introduction, the guidewire was unable to advance at the hub and the balloon catheter got stuck with the guidewire.The shaft was cut and the guidewire was reinserted; however, it was noted that the shaft got kinked.The guidewire and the balloon catheter were removed and the procedure was completed with a different device.No patient complications nor injuries were reported.

Manufacturer Narrative

A2-age at time of event: 18 years or older e1-initial reporter address 1: (b)(6) e1-initial reporter city: (b)(6).Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the device returned in three pieces.The first piece is 9.9cm long from the hub to the separation.The middle piece is approximately 50.8cm long.The distal section is approximately 88.6cm from the tip to the separation.Microscopic examination revealed no additional damages.A test guidewire was attempted to be inserted into the three pieces but it would not pass through the section with the hub.It was found that the guidewire lumen inside the hub is buckled.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that device entrapment occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified below-the-knee vessel.A 1.5mm x 20mm x 142cm coyote es balloon catheter was advanced for dilatation.During guidewire exchange, a 235cm jupiter fc3 guidewire was removed without resistance and was replaced with a 300cm jupiter fc guidewire.However, during introduction, the guidewire was unable to advance at the hub and the balloon catheter got stuck with the guidewire.The shaft was cut and the guidewire was reinserted; however, it was noted that the shaft got kinked.The guidewire and the balloon catheter were removed and the procedure was completed with a different device.No patient complications nor injuries were reported.

• Brand Name: COYOTE ES
• Type of Device: 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: 14489775
• MDR Text Key: 292569672
• Report Number: 2134265-2022-05244
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767329
• UDI-Public: 08714729767329
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0026442188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: MACH1; GUIDE CATHETER: MACH1; GUIDEWIRE: JUPITER; GUIDEWIRE: JUPITER; INFLATION DEVICE: GM30; INFLATION DEVICE: GM30; INTRODUCER SHEATH: TERUMO; INTRODUCER SHEATH: TERUMO
• Patient Sex: Male