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 08/22/2019

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4mm x 40mm x 146cm coyote es balloon catheter was advanced for dilatation.However, during the second inflation at 8 atmospheres for 60 seconds, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

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.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.The device was soaked in a water bath for five days to loosen the blood and contrast in the device.There was a pinhole at the distal marker band.There was no marker band damage detected.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4mm x 40mm x 146cm coyote es balloon catheter was advanced for dilatation.However, during the second inflation at 8 atmospheres for 60 seconds, the balloon ruptured.The procedure was completed with a different device.No patient complications 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
• MDR Report Key: 8948278
• MDR Text Key: 156098222
• Report Number: 2134265-2019-10463
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767312
• UDI-Public: 08714729767312
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2022
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0024104491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 10/04/2019
• Supplement Dates FDA Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: CRUISE; GUIDE WIRE: CRUISE; INTRODUCER SHEATH: DESTINATION 6F 45CM; INTRODUCER SHEATH: DESTINATION 6F 45CM; GUIDE WIRE: CRUISE; INTRODUCER SHEATH: DESTINATION 6F 45CM