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

Model Number 24691

Device Problems Material Rupture (1546); Failure to Advance (2524)

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

Event Date 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address 1: (b)(6).

Event Description

It was reported that balloon rupture occurred. Vascular access was obtained utilizing a crossover approach. The 100% stenosed target lesion was located in the severely tortuous and severely calcified iliac artery. After the lesion was crossed with jupiter max guidewire, a 2mm x 20mm x 143cm coyote es balloon catheter was advanced but failed to cross the lesion. Subsequently, a 1. 5mm x 20mm x 143cm coyote es balloon catheter was advanced, but it also failed to cross the lesion. The crossover was discontinued and a change to the approach from the left bra was performed. After the lesion was crossed again with jupiter max guidewire, a 1. 5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation, however, during inflation at 8 atmospheres, the balloon ruptured. A 2mm x 20mm x 143cm coyote es balloon catheter was advanced, but it also ruptured during inflation. The procedure was completed with a 4mmx2cm coyote balloon catheter. There were no patient complications 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: 12750323
• MDR Text Key: 280063108
• Report Number: 2134265-2021-13865
• 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: company representative,distri

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0026936959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial