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

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: cath lab coordinator.A review of the device history record of the product code/lot number combination was conducted with no findings.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
The user facility reported that a radial left heart catheterization was being performed.The fellow had obtained access with no resistance and there was good flow back after the sheath was inserted.When pulling the dilator, there was resistance and the wire then unraveled.A bit of the wire was left in the patient.The patient was then seen by a vascular surgeon and the wire was left alone for medical therapy.The procedure was completed via a femoral approach.A piece of the wire was left in artery wall of the patient.The patient was seen by vascular surgery; however, there was no surgical intervention.The patient was in stable condition.No equipment or other devices were used with the product involved.
Additional Manufacturer Narrative
One 6fr gss guidewire was returned for product evaluation.The guidewire was separated at 37cm from the stiff end, with the coil unraveled at the separation.The complaint can be confirmed for guidewire separation based on the condition of the returned device.The exact root cause could not be determined.The complaint mentions that resistance was felt during the withdrawal of the guidewire when the guidewire separated.The likely root cause of this event is that the guidewire became caught and separated due to the tensional forces applied by the user during withdrawal.Review of device history record (dhr) showed there were no issues noted during manufacture of the product that could have contributed to this complaint condition.Currently no action is recommended since this risk evaluation is within the predetermined limits in the design failure mode and effects analysis (dfmea).
Event or Problem Description
Additional information was received on 23 may 2023: there was mild calcium, but no tortuosity.There were no clinical consequences from the retained wire.

• Brand Name: GLIDESHEATH
• Common Device Name: 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 ; 6402040886
• MDR Report Key: 16962969
• Report Number: 1118880-2023-00098
• Device Sequence Number: 5244154
• Product Code: DYB
• UDI-Device Identifier: 00389701011134
• UDI-Public: 00389701011134
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K152173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 20-1060
• Device Lot Number: 0000196916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown