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

Model Number 24691

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that balloon rupture occurred.The target lesion was located in the moderately tortuous and moderately calcified external iliac artery.A 4 mm x 20 mm x 144 cm coyote es balloon catheter was advanced for dilatation and was inflated twice at 14 atmospheres for a few seconds.However, during the third inflation at 14 atmospheres for a few seconds, the balloon ruptured.The device was completely removed from the patient.The procedure was completed with another of same 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: 11194490
• MDR Text Key: 227547549
• Report Number: 2134265-2021-00449
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767299
• UDI-Public: 08714729767299
• 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: Physician
• Type of Report: Initial
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2023
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0025805961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• 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: GUIDEWIRE: 014GW; INTRODUCER SHEATH: 6F DESTINATION