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

Model Number 24699

Device Problem Deflation Problem (1149)

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

Event Date 07/09/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that deflation failure occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified anterior tibial artery.A 2.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilation.However, during deflation, the balloon failed to deflate.The device was removed via the sheath.The procedure was completed with a different device.There were no patient complications reported.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) medical center.E1: initial reporter city: (b)(6).Device evaluated by mfr.: returned product consisted of a coyote balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.The device was inflated to rated burst pressure and then deflated without any issues.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the failure to deflate.

Event Description

It was reported that deflation failure occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified anterior tibial artery.A 2.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilation.However, during deflation, the balloon failed to deflate.The device was removed and completed the procedure with a different device.There were no patient complications reported.

• Brand Name: COYOTE
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12263618
• MDR Text Key: 264699867
• Report Number: 2134265-2021-09699
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729796817
• UDI-Public: 08714729796817
• Combination Product (y/n): N
• PMA/PMN Number: K111295
• 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: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2023
• Device Model Number: 24699
• Device Catalogue Number: 24699
• Device Lot Number: 0025529210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1