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

Model Number N/A

Device Problem Positioning Problem (3009)

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

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device not implanted.Explanted date: device not explanted.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.

Event Description

The user facility reported that the physician accessed with the glidesheath slender needle and wire, and the wire would not advance out of the needle, so they removed the needle and wire and then opened a new kit.There was no patient injury, medical/surgical intervention required.The patient's condition was stable.The procedure outcome was successful.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information in section b5.

Event Description

Additional information was received on 24aug2021.The type of procedure being performed was a left heart catheterization.

Manufacturer Narrative

This report is being submitted as follow up no.2 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record of the product code/lot# combination was conducted with no findings.Since the sample is not available for evaluation, the complaint cannot be confirmed.The exact root cause cannot be determined.The dhr review determined that 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.

• Brand Name: GLIDESHEATH SLENDER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 12341159
• MDR Text Key: 267274355
• Report Number: 1118880-2021-00195
• 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,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 80-1060
• Device Lot Number: 0000043138
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1