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 02/21/2024

Event Type  malfunction  

Event Description

The user facility reported that the involved glidesheath slender device was successfully introduced into the patient's radial artery but leaked blood throughout the case from one (1) way valve.The estimated blood loss less than 250 cc.The event occurred intra-operative.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.The patient was not injured during the event and medical/surgical intervention was not needed.Additional information was received on 27 feb 2024: procedure was a left heart catheterization.The blood leakage was confirmed to being leaking from the cc value.The account continued the case as it was a normal cath.

Manufacturer Narrative

A1: patient identifier: not available due to hospital policy.A2: age or date of birth: not available due to hospital policy.A3a: sex: not available due to hospital policy.A3b: gender: n/a.A4: weight: not available due to hospital policy.A5: ethnicity: not available due to hospital policy.A6: race: not available due to hospital policy.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual device is not available for return.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: 19009045
• MDR Text Key: 339035373
• Report Number: 1118880-2024-00036
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701012070
• UDI-Public: 00389701012070
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2024
• 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: 80-1065
• Device Lot Number: 0000459330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2023
• 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