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

Model Number 24691

Device Problems Break (1069); Difficult to Remove (1528); Material Rupture (1546); Stretched (1601); Material Integrity Problem (2978)

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

Event Date 11/08/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that removal difficulties, balloon rupture, and shaft break occurred. The patient underwent percutaneous transluminal angioplasty (pta) for graft occlusion after bypass from the superficial femoral artery to the popliteal. The stenosed target lesion was located in the moderately tortuous and non calcified below the knee vessel. A 4f introducer sheath was positioned. After crossing the wire, the anterior tibial artery (ata) and posterior tibial artery (pta) were dilated with 2. 0 x 4 coyote balloon catheter. A 4mm x 40mm x 146cm coyote es balloon catheter was then used to dilate the trunk section. There was no resistance noted during balloon delivery. The 4mm x 40mm x 146cm coyote es balloon catheter was deflated and there was resistance noted during removal of the balloon catheter from the lesion. At that time, the 4mm x 40mm x 146cm coyote es balloon catheter ruptured and the shaft broke. The introducer sheath was changed to 6f, and the separated 4mm x 40mm x 146cm coyote es balloon catheter was retrieved with a snare. In retrieving the 4mm x 40mm x 146cm coyote es balloon catheter, the shaft was elongated and twisting was also observed. The procedure was completed and 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: 12885290
• MDR Text Key: 281354554
• Report Number: 2134265-2021-14349
• 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: Foreign,Health Professional,Company Representative,Distributor

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0027762202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/29/2021 Patient Sequence Number: 1

Treatment

GUIDEWIRE: GLADIUS; INTRODUCER SHEATH: 4F 25CM