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 04/14/2022

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified anterior tibial artery.Two balloon catheters were advanced for dilatation.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced; however, on the first inflation at 6 atmospheres for 30 seconds, the balloon ruptured.The device was removed without any problem.Subsequently, another 2mm x 20mm x 143cm coyote es was advanced but the device was unable to cross the lesion.During removal, it was noted that the shaft was broken.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient condition was good.

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 moderately tortuous and severely calcified anterior tibial artery.Two balloon catheters were advanced for dilatation.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced; however, on the first inflation at 6 atmospheres for 30 seconds, the balloon ruptured.The device was removed without any problem.Subsequently, another 2mm x 20mm x 143cm coyote es was advanced but the device was unable to cross the lesion.During removal, it was noted that the shaft was broken.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient condition was good.

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.Kinks 33.5 cm and 35.2 cm from the distal tip were seen.A rupture of the balloon was confirmed 15 mm from the tip.Device analysis determined the condition of the returned device was consistent with the reported information of a rupture.

• 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: 14287886
• MDR Text Key: 290777891
• Report Number: 2134265-2022-04549
• 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: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• 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: 0028619154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2022
• 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