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

Model Number 24701

Device Problem Material Puncture/Hole (1504)

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

Event Date 12/13/2023

Event Type  malfunction  

Event Description

It was reported that the wire perforated the device.The patient underwent percutaneous transluminal angioplasty procedure of the posterior tibial artery.A 1.5mm x 20mm x 142cm coyote es balloon catheter was advanced with jupiter fc guidewire as a support catheter.After that, in order to replace it with jupiter sfc guidewire, the fc wire was removed while leaving the device in the blood vessel and replaced with sfc wire.While advancing the sfc wire to the guidewire lumen of the corresponding device, the guidewire lumen was pierced and the sfc got into the blood vessel.The balloon and entire guidewire were removed, and the sfc wire was confirmed to have penetrated the balloon shaft.The procedure was performed using the same system, resulting in successful revascularization.No patient complications nor injuries were reported.

Event Description

It was reported that the wire perforated the device.The patient underwent percutaneous transluminal angioplasty procedure of the posterior tibial artery.A 1.5mm x 20mm x 142cm coyote es balloon catheter was advanced with jupiter fc guidewire as a support catheter.After that, in order to replace it with jupiter sfc guidewire, the fc wire was removed while leaving the device in the blood vessel and replaced with sfc wire.While advancing the sfc wire to the guidewire lumen of the corresponding device, the guidewire lumen was pierced and the sfc got into the blood vessel.The balloon and entire guidewire were removed, and the sfc wire was confirmed to have penetrated the balloon shaft.The procedure was performed using the same system, resulting in successful revascularization.No patient complications nor injuries were reported.

Manufacturer Narrative

Device evaluated by mfr.: the 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 no damages.Microscopic examination revealed a hole in the shaft 51.2cm from the hub.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; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18486365
• MDR Text Key: 332572901
• Report Number: 2124215-2023-75683
• Device Sequence Number: 1
• Product Code: LIT
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0031124986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2023
• 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: GUIDEWIRE: JUPITER FC AND SFC; GUIDEWIRE: JUPITER FC AND SFC