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

Model Number 24691

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

Returned product consisted of a coyote es balloon catheter.The balloon was loosely folded, with contrast in the inflation lumen/shaft.The device soaked in a warm water bath for 6 days.The tip, balloon, markerbands, inner/outer shaft were microscopically and visually inspected.Inspection revealed numerous kinks in the hypotube, and a pinhole in the balloon material located at the distal edge of the distal markerband.The device was functionally tested by attaching an inflation device (filled with water), to the hub of the coyote es.When positive pressure was applied, water was found to be streaming out from a pinhole in the balloon material, and pressure could not be maintained.Inspection of the remainder of the device found no other damage or irregularities.

Event Description

Reportable based on device analysis completed on (b)(6) 2019.It was reported that the balloon was defective.The target lesion was located in the ureter.A 2mmx20mmx143cm coyote balloon catheter was selected for use but balloon breakdown was noted.There were no patient complications reported.However, returned device analysis revealed balloon pinhole.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8375506
• MDR Text Key: 137376242
• Report Number: 2134265-2019-01715
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767176
• UDI-Public: 08714729767176
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K093636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2021
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0022480250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2018
• 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 Age: 55 YR