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

Model Number 24691

Device Problem Material Rupture (1546)

Patient Problem No Patient Involvement (2645)

Event Date 06/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the internal carotid to common carotid artery.A 2.5mm x 40mm x 146cm coyote es balloon catheter was selected for use.During preparation, it was noted that air was continuously pulled despite it being vacuumed for removal which indicates that there was a leak/hole in the device.Subsequently, the length was changed to 30mm to continue as there was no balloon of the same size.The procedure was completed and there were no patient complications nor injuries reported.

Event Description

It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the internal carotid to common carotid artery.A 2.5mm x 40mm x 146cm coyote es balloon catheter was selected for use.During preparation, it was noted that air was continuously pulled despite it being vacuumed for removal which indicates that there was a leak/hole in the device.Subsequently, the length was changed to 30mm to continue as there was no balloon of the same size.The procedure was completed and there were no patient complications nor injuries reported.

Manufacturer Narrative

(e1)- initial reporter city: (b)(6).Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.The balloon was tightly folded.The device was soaked in a water bath for one hour to loosen the blood and contrast in the device.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole 1mm distal from the proximal marker band.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported balloon ruptured.

• Brand Name: COYOTE ES
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10275576
• MDR Text Key: 198873130
• Report Number: 2134265-2020-08635
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767220
• UDI-Public: 08714729767220
• Combination Product (y/n): N
• PMA/PMN Number: K093636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2023
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0025332981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: FILTERWIRE EZ/190CM/STRYKER; GUIDE WIRE: FILTERWIRE EZ/190CM/STRYKER; GUIDING CATHETER: FLOWGATE2/8R85CM/JAPAN STRIKER; GUIDING CATHETER: FLOWGATE2/8R85CM/JAPAN STRIKER; INTRODUCER SHEATH: 8FR25CM/MEDIKIT; INTRODUCER SHEATH: 8FR25CM/MEDIKIT; GUIDE WIRE: FILTERWIRE EZ/190CM/STRYKER; GUIDING CATHETER: FLOWGATE2/8R85CM/JAPAN STRIKER; INTRODUCER SHEATH: 8FR25CM/MEDIKIT
• Patient Age: 80 YR