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

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the guidewire in the glidesheath slender kit got stuck inside of the provided needle and requires manipulation to successfully pass through the needle.Patient condition was stable, and the procedure was completed successfully.Additional information was received on 21 jun 2022: the procedure for the patient was a peripheral angiogram with angioplasty and atherectomy of right lower extremity.They did not switch to a new glidesheath slender (gss) to complete the procedure.
Additional Manufacturer Narrative
Patient identifier: requested, not provided.Patient sex: requested, not provided.Weight: requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to update sections d9 and h3 and to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for guidewire and needle mobility issues because the sample was not returned for assessment.The exact root cause could not be determined.There is no indication that any manufacturing, design or quality system issues may have led to this event.Currently no action is recommended since device was within manufacturing and design specifications when it was released from terumo medical corporation control.

• 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: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14926166
• Report Number: 1118880-2022-00051
• Device Sequence Number: 20287089
• Product Code: DYB
• UDI-Device Identifier: 00389701011912
• UDI-Public: 00389701011912
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K193160
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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: 06/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 51-1050
• Device Lot Number: 0000130934
• 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: 06/09/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• 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: 77 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White