MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION DESTINATION RENAL 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)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not 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 destination device was used in a peripheral vascular procedure.The sheath performed correctly during the procedure.While removing the sheath, the hub became disconnected from the shaft of the sheath.There was no reported blood loss and there was no harm to the patient from this event.The patient's condition was stable, and the procedure was a success.There was no patient injury, medical/surgical intervention required.Additional information was received on 10jun2020.There were no particles reported.The breaking of the sheath seemed to have happened during removal.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information in section b5, to update section d10 and section h3, and to provide the completed investigation results.It was initially reported that the actual device was available for evaluation; however, it was confirmed that the user facility discarded the actual device and is no longer available.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.
Event or Problem Description
Additional information was received on 07jul2020.It was confirmed that the breakage occurred at the sheath shaft.The customer stated the inner and outer layers of the sheath shaft broke from the sheath hub.

• Brand Name: DESTINATION RENAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton, md
• MDR Report Key: 10205660
• Report Number: 1118880-2020-00144
• Device Sequence Number: 19366551
• 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): 06/29/2020

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: 54-64501
• Device Lot Number: YC05
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1