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

Model Number	N/A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- inventory coordinator.The actual device has been 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.
Event or Problem Description
The user facility reported that the involved glidesheath slender was used during a right radial coronary angiogram, access was gained with the needle in the kit.The wire in the kit would not advance through the needle.A new kit was opened and the wire from that kit was used to advance through the needle without issue.The procedure continued without issue.The patient's condition was stable, and they were discharged.The procedure was completed successfully.The estimated blood loss was less than 250cc's.There was no patient injury, medical/surgical intervention required.Additional information was received on 18sep2020.The physician stated that when the wire would not fit through the needle in the kit, they opened another kit and that wire did fit through the needle.She tried putting the wire that was returned through the needle from the second kit and it would not go through that needle either.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1.This reported event has been deemed not reportable based off the investigation of the actual device; inspection of the returned sample upon receipt found that the device had no damage and there were no issues inserting the wire into a needle.Therefore, this event is currently deemed a nonreportable event.

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 10641475
• Report Number: 1118880-2020-00245
• Device Sequence Number: 11401755
• Product Code: DYB
• UDI-Device Identifier: 00389701012117
• UDI-Public: 00389701012117
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

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: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 80-1660
• Device Lot Number: YC05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NEEDLE AND GUIDEWIRE FROM RADIAL KIT.