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

Model Number 24706

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: returned product consisted of a coyote balloon catheter with the balloon protector on the balloon.The outer shaft, inner shaft, balloon and tip were microscopically examined.The shaft is kinked in numerous locations.The inner shaft is stretched.The outer shaft was torn/separated 23.5cm from the distal tip.The fractured/separated end of the shaft was stretched and jagged which indicates the shaft separation was due to tensile forces.The balloon protector was taken off of the balloon during analysis with no issues.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on device analysis completed on 20-dec-2018.It was reported that balloon outer protective sheath removal difficulties were encountered and device damage/defective occurred.During preparation of a 2.0mm x 220mm x 150cm coyote balloon catheter, it was noted that the balloon protector was difficult to remove and the plastic outer sheath, the clear plastic outer of the balloon, broke.No patient complications were reported.However, returned device analysis revealed shaft detached/separated.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8246968
• MDR Text Key: 133040268
• Report Number: 2134265-2018-65064
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2019

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: 04/09/2021
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0021969711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2018
• 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