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

Model Number 24701

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

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

Event Date 03/11/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter address 1:(b)(6).

Event Description

It was reported that balloon rupture occurred.The target lesion was located in the severely tortuous posterior tibial artery.A 1.5mm x 20mm x 142cm coyote es balloon catheter was advanced for dilatation.However, during initial inflation at 10 atmospheres for 30 seconds, the balloon ruptured.Subsequently, the stump was collected using a snare.However, it was unknown whether all the ruptured portion was collected.The procedure was completed with a different device.There were no patient complications reported and the patient was in good condition after the procedure.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter.The outer shaft and hub were not returned, the balloon was returned, the inner shaft was received.The inner shaft was measured at 14.8 cm long.Microscopic analysis found buckling to the inner shaft 5.7 cm to the end of the shaft.Kinks were found at 6.5 cm and 5.8 cm from the distal end.The balloon was soaked to soften the crystal formation of the saline and examined for a rupture.Microscopic inspection of the balloon appeared to be whole in its detached state from the catheter but could not be inflated to confirm material rupture.

Event Description

It was reported that balloon rupture occurred.The target lesion was located in the severely tortuous posterior tibial artery.A 1.5mm x 20mm x 142cm coyote es balloon catheter was advanced for dilatation.However, during initial inflation at 10 atmospheres for 30 seconds, the balloon ruptured.Subsequently, the stump was collected using a snare.However, it was unknown whether all the ruptured portion was collected.The procedure was completed with a different device.There were no patient complications reported and the patient was in good condition after the procedure.

• 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: 14058289
• MDR Text Key: 288913085
• Report Number: 2134265-2022-03313
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767329
• UDI-Public: 08714729767329
• 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: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2023
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0027280287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2021
• 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
• Patient Outcome(s): Required Intervention