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

Model Number 24691

Device Problem Material Rupture (1546)

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

Event Date 05/23/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the severely calcified below the knee vessel.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilation.However, during the third inflation at 10 atmospheres for 30 seconds, the balloon ruptured.The device was removed and the procedure was completed with a different device.There were no patient complications and the patient was in good condition.

Manufacturer Narrative

(e1) initial reporter city: (b)(6).Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.The device showed signs of use.Microscopic investigation revealed a pinhole in the balloon 1.4 cm from the distal tip of the balloon.No other damage was seen.

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the severely calcified below the knee vessel.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilation and was inflated twice for 6 atmospheres for 30 seconds.However, during the third inflation at 10 atmospheres for 30 seconds, the balloon ruptured.The device was removed and the procedure was completed with a different device.There were no patient complications and the patient was in good condition.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14526765
• MDR Text Key: 293064330
• Report Number: 2134265-2022-06130
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767169
• UDI-Public: 08714729767169
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

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 Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0028807454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 05/27/2022
• Supplement Dates Manufacturer Received: 07/13/2022
• Supplement Dates FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2022
• 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: INFLATION DEVICE: ENCORE 26; INFLATION DEVICE: ENCORE 26; INTRODUCER SHEATH: 5FR DESTINATION; INTRODUCER SHEATH: 5FR DESTINATION