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

Model Number N/A

Device Problems Difficult to Insert (1316); Material Deformation (2976)

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

Event Date 04/16/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device not implanted.Explanted date: device not explanted.The actual device has 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 they prep the table prior to the patient entering the room.They tested the glidesheath slender wire through the access needle and felt a slight bump on the wire that caused resistance going through the needle, they could have forced it through.A second glidesheath slender was opened and used successfully.The left heart catheterization (lhc) was successful.There were no other devices or equipment used with the reported product.

Manufacturer Narrative

This reported event has been deemed not reportable based off the investigation of the actual device; inspection of the returned sample upon receipt found that the device had no visual, dimensional or functional anomalies.The device involved in this complaint has been verified to be of normal product; therefore, is not a reportable event.

• Brand Name: GLIDESHEATH SLENDER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11911179
• MDR Text Key: 255831390
• Report Number: 1118880-2021-00113
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

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: 04/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 80-1060
• Device Lot Number: 0000015893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 06/01/2021
• Supplement Dates Manufacturer Received: 07/07/2021
• Supplement Dates FDA Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1