MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION GLIDESHEATH SLENDER; INTRODUCER, CATHETER

Model Number N/A

Device Problem Separation Problem (4043)

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

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter occupation - lab manager.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.This report is for the second device reported, for the first device reported that was used on the same patient see mdr 118880-2021-00215.

Event Description

The user facility reported that the glide-sheath slender was in the dorsalis pedis, and angioplasty was performed with a 0.18" saber balloon.When the balloon was removed it took the body of the sheath with it, leaving only the hub in its place.When the balloon was inspected it was found that the sheath was stuck to the balloon.A 5/6 slender sheath was inserted in its place, and an abbott armanda 0.18" balloon was used to continue the case.When the balloon was removed the same thing happened again and the body of the slender sheath was detached from the hub and stuck on the balloon.The estimated blood loss was less than 250cc's.The patient recovered and the procedure outcome was successful.Additional information was received on 02decmeber2021: there was no medical intervention required as a result of the sheath issues.A second device was used and also failed.Therefore a third slender sheath was used, however, they were done intervening on the patient, so they just took their final pictures using that sheath and concluded the case.Nothing was left in the patient anatomy.The patient was stable.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for sheath mobility issues because the sample was not returned for assessment.The exact root cause cannot be determined.Review of dhr showed there were no issues noted during manufacture of the product that could have contributed to this complaint condition.Currently no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea).

• Brand Name: GLIDESHEATH SLENDER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: mary o'neill ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 13076841
• MDR Text Key: 286138175
• Report Number: 1118880-2021-00216
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00038970101263
• UDI-Public: 0038970101263
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 80-1060
• Device Lot Number: 0000000280
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2020
• 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: 0.18" SABER BALLOON; ABBOTT ARMANDA BALLOON