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

Model Number	N/A
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo medical received a user facility medwatch report # (b)(4).The event description states that they were unable to advance the catheter through the sheath.The original intended procedure was a left heart catheterization.Device malfunction, the device did not do what it was supposed to do.Location of event occurred in the hospitals or.Patients preexisting characteristics that may have contributed to the event was coronary heart disease.Additional information was received on 27 jan 2023: the estimated blood loss was 200 to 400 ml.The patient condition was critical but not related to the event.Impelled due to other complications.It was unknown if any devices were used with the involved device.
Additional Manufacturer Narrative
Date of birth: requested, but unknown; weight: requested, but unknown; ethnicity: requested, but unknown; implanted date: device was not implanted; explanted date: device was not explanted; initial reporter occupation: associate clinical data analyst.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for sheath mobility issues because the sample was not returned for assessment.Without a sample, the exact root cause could not be determined.Review of device history record (dhr) review 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).A review of the device history record of the product code/lot number combination was conducted with no findings.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the maude report assoicated with this reported event.Terumo tmc performed a maude search on 27 feb 2023.Report number 16246253 was found and was confirmed to be the same reported event; therefore, the maude report has been provided.

• 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: 16394933
• Report Number: 1118880-2023-00011
• Device Sequence Number: 17564226
• Product Code: DYB
• UDI-Device Identifier: 00389701012124
• UDI-Public: 00389701012124
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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: 04/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 80-1670
• Device Lot Number: 0000088050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2021
• 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
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 30 KG
• Patient Ethnicity: Non Hispanic