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

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device not implanted.Explanted date: device not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.

Event Description

The user facility reported that the wire would not go through the needle in the 6fr glidesheath slender stainless-steel kit.There was no patient injury/medical or surgical intervention required.The patient was stable, and the procedure outcome was successful.

Event Description

Additional information was received on 22jan2021.The reporter was not aware of the needle being bent.The wire was unable to go through the needle when it was being prepped.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information in section b5, to update section d9, to update section h3, and to provide the completed investigation results.One 6fr glidesheath slender guidewire and needle were returned for product evaluation.Visual inspection revealed that there was a significant bend on the needle and the guidewire.The guidewire was placed inside a plastic hoop and an extensive bend was seen on the wire where the hoop ended.Similarly, the needle was also extensively bent.Blood like substances were seen inside the needle.The floppy end weld of the guidewire was viewed under microscope and was intact.Dimensional testing was performed.Measurements of the guide wire were taken, and the diameter of the wire was 0.510 mm which was within the manufacturer specification of 0.51-0.54 mm.Functional testing was performed.The guidewire could not be inserted into the needle since the needle and the guidewire was extensively bent.Uncoiling was not observed on the guidewire floppy end weld.The complaint can be confirmed for guide wire mobility.The guidewire could not be inserted into the needle and uncoiling was not observed on the guidewire floppy end weld.Based on the investigation, the cause of the event could be due to off- axis brute forces that led to deformation of the guidewire and the needle which prevented the guidewire to advance through the needle.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the fmea.

• Brand Name: GLIDESHEATH SLENDER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11078294
• MDR Text Key: 223825464
• Report Number: 1118880-2020-00337
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701012063
• UDI-Public: 00389701012063
• Combination Product (y/n): N
• PMA/PMN Number: K173831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 80-1060
• Device Lot Number: 000006195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1