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

Lot Number 21817795

Device Problems Entrapment of Device (1212); Material Rupture (1546)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/07/2019

Event Type  Injury  

Event Description

Balloon ruptured during angioplasty of right anterior tibial artery.During removal of balloon, the catheter severed and distal 2/3rd's of balloon and tip remained in artery.Snare device was used to successfully retrieve the balloon/tip.Additional radiation and contrast was used in order to retrieve device.

• Brand Name: BOSTON SCIENTIFIC COYOTE ES
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.
• MDR Report Key: 8239555
• MDR Text Key: 133319076
• Report Number: MW5083058
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767411
• UDI-Public: 08714729767411
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 21817795
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 86