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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the operator gained access with the needle in the glidesheath slender kit.He inserted the wire through the needle.He stated that it did not feel correct when inserting the wire.He pulled back on the wire and noticed the wire had become unraveled.He then pulled the wire and sheath together out of the patient's body and held pressure at the puncture site.Upon removal, he noticed that the wire was longer and unraveled at the distal tip.The patient was in stable condition.The estimated blood loss was less than 250cc.The procedure outcome was successful.Additional information was received on 10may2023: the procedure taking place was a diagnostic left heart catheterization.They continued the case by opening another package and proceeded with case.They ran the wire through the needle provided in our glidesheath slender nitinol kit.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: lead tech.A review of the device history record of the product code/lot number combination was conducted with no findings.One 5fr gss guidewire was returned for assessment.The guidewire was separated 40cm from the stiff end of the wire, with the coil holding the two separated pieces of guidewire together.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 descriptions mentions that there was difficulty advancing the guidewire and that it was pulled back through the needle.The guidewire may have become stuck or damaged at this point which could have caused it to separate 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 & effects analysis (dfmea).

• Brand Name: GLIDESHEATH SLENDER
• 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: 17124968
• Report Number: 1118880-2023-00273
• Device Sequence Number: 6448905
• Product Code: DYB
• UDI-Device Identifier: 00389701011363
• UDI-Public: 00389701011363
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K173831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 50-1050
• Device Lot Number: 0000279301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NEEDLE FROM GLIDESHEATH SLENDER NITINOL KIT
• Patient Sex: Unknown