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 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter occupation: interventional cardiologist.The actual device was returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.

Event Description

The user facility reported that the doctor stated that the 6fr guide catheters felt tight going through the 6fr glidesheath slender (gss).They also felt this with a 6fr multipurpose diagnostic catheter.The manager and staff state no other doctor was having this issue, and they use the same products.The doctor uses the snuff box technique often, as he did on this case.Additional information was received on 06 jun 2022: the doctor is stating specifically glidesheath slender (gss) mobility difficulty with said competitor devices, cordis multi -purpose diagnostic catheter and medtronic 6fr al guide devices.The snuff box technique is going between the thumb and finger, instead of thru the radial artery wrist.The patient was stable.There was no blood loss.There was no issue with intervention and case completed successfully.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.H6: investigation findings - 3211 is based upon evaluation of user facility information and the returned sample; 213 is based upon the functional and dimensional testing.H6 - conclusion - 4310 is based upon evaluation of user facility information and the returned sample; 67 is based upon the functional and dimensional testing.One 6fr glidesheath slender (gss) dilator and sheath, one mp diagnostic catheter, and one medtronic guide catheter were returned for product evaluation/assessment.A kink was observed on the sheath and measured to be 0.4cm from the hub.Functional testing was performed.The catheters were both successfully fully passed through the sheath without resistance.The outer diameter (od) of the catheters were measured to be 0.831" and 0.798".The inner diameter (id) of the terumo sheath was measured to be 0.085" from the tip end.The specification for sheath id is >/=0.085".The complaint cannot be confirmed for sheath mobility issues as sheath id was found to be in specifications.And to have functioned as intended.The exact root cause could not 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 design failure mode & effects analysis (dfmea).

• 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: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14859735
• MDR Text Key: 302961416
• Report Number: 1118880-2022-00035
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701012063
• UDI-Public: 00389701012063
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 80-1060
• Device Lot Number: 0000154195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2022
• 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: COMPETITORS MP DIAGNOSTIC; MEDTRONIC 6FR AL GUIDE CATH