MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION DESTINATION PERIPHERAL GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was 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.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 destination hub was not connected to the sheath.The hub fell on the floor when the sterile package was opened.A new sheath was opened.Additional information was received on 27apr2020.The issue occurred during prepping, without the patient present.Sine the hub was not attached, it fell on the floor.There was no patient injury, medical/surgical intervention required.Additional information was received on 05may2020.The reported event was discovered upon opening the package.The procedure being performed was an angiogram of the lower extremities.The patient's condition was stable.Another sheath was opened, and the procedure was completed.Additional information was received on 06may2020.A new terumo sheath was opened, and the case was continued with successful turnouts.The patient was present when the issue occurred.
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 for evaluation; however, a photograph of the actual device was returned for evaluation.Therefore, the investigation was based upon the user facility information and a photograph provided by the user facility.Visual inspection of the provided image revealed that the valve assembly was unscrewed from the sheath in the package tray.No other anomalies were noted.It is likely that the valve assembly could have unscrewed from the sheath hub at an unknown time postproduction.However, with no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: DESTINATION PERIPHERAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton, md
• MDR Report Key: 10061822
• Report Number: 1118880-2020-00109
• Device Sequence Number: 3514704
• Product Code: DYB
• UDI-Device Identifier: 00389701008837
• UDI-Public: 00389701008837
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2020

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: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 54-64501
• Device Lot Number: YA22
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR