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

Model Number N/A

Device Problem Leak/Splash (1354)

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

Event Date 02/16/2024

Event Type  malfunction  

Event Description

The user facility reported that the involved sheath was used during a routine left heart catheterization (lhc) case.The physician reported valve leakage around the catheter during the case despite trying to center.The specific catheter used in conjunction was not reported.The estimated blood loss was less than 250cc's.The event occurred intra-operative.The reported event did not result in patient injury and/or required medical or surgical intervention.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.

Manufacturer Narrative

D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: registered technician (rt).The actual device was not available; therefore, the actual device will not be returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.

• 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: gina digioia ; 950 elkton blvd; elkton, MD 21921 ; 4103927218
• MDR Report Key: 18887358
• MDR Text Key: 337460897
• Report Number: 1118880-2024-00025
• 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
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• 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: 0000466594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/29/2023
• 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
• Patient Age: 79 YR
• Patient Sex: Male