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 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that deflation failure occurred.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee.A 3.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.After inflating at 6 atmospheres, the device could not completely deflate.Upon withdrawal, the balloon was about 3/4 of the way deflated.The balloon catheter was then successfully removed while rotating it.The procedure was completed with another of same device.No patient complications were reported.

• Brand Name: COYOTE
• 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: 11296808
• MDR Text Key: 230953326
• Report Number: 2134265-2021-01033
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729796961
• UDI-Public: 08714729796961
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2021

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: 09/25/2023
• Device Model Number: 24699
• Device Catalogue Number: 24699
• Device Lot Number: 0026077694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2020
• 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: GUIDE CATHETER: PARENT; GUIDEWIRE: VASALLO; MICRO CATHETER: FENCER