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 02/29/2024

Event Type  malfunction  

Event Description

The user facility reported that the involved glidesheath slender device sheath value leaked.Blood loss was less than 250 cc.Leakage occurred three times during the same patient heart cath, and the leakage was described as minimal.They replaced each gss with another of the same lot and each time it leaked again.There was no harm to patient who is stable condition.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.

Manufacturer Narrative

A1: patient identifier: requested, not provided a2: age or date of birth: requested, not provided a3a: sex: requested, not provided a3b: gender: n/a a4: weight: requested, not provided a5: ethnicity: requested, not provided a6: race: requested, not provided d6a: implanted date: device was not implanted d6b: explanted date: device was not explanted e3: occupation: lab manager 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: 19009058
• MDR Text Key: 339001624
• Report Number: 1118880-2024-00039
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2024

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: 80-1060
• Device Lot Number: 0000463186
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2023
• 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