MAUDE Adverse Event Report: GLIDESHEATH; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device not implanted.Explanted date: device not explanted.The actual device was not 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 the patient was stable and that there were no issues with the outcome of the procedure.There was no patient injury, medical/surgical intervention required.Additional information was received on (b)(6) 2021: the valve was leaking during the case.The leak was at the end of the valve.The leak occurred during the flushing of the device.The blood loss was less than 250cc's.The procedure was completed with the device.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 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 the leaking valve that user experience since the sample was not returned for evaluation.Based on the information given, the exact root cause of the event cannot be determined.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently, no action is recommended since the device was within manufacturing and design specifications when it was released from terumo medical corporation control.A review of the device history record of the product code/lot# combination was conducted with no findings.

• Brand Name: GLIDESHEATH
• Common Device Name: INTRODUCER, CATHETER
• MDR Report Key: 12514462
• Report Number: 1118880-2021-00202
• Device Sequence Number: 14296733
• Product Code: DYB
• UDI-Device Identifier: 00389701011189
• UDI-Public: 00389701011189
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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: 05/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 20-2565
• Device Lot Number: 0000023124
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• 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