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	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has 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 hub was not attached to the destination sheath when the packaging was opened.This caused the hub to fall and a new destination sheath had to be opened and used.The procedure outcome was a success.There was no patient injury/medical or surgical intervention required.Additional information was received on 19may2020.The procedure performed was a leg case.The sheath catheter hub was not attached, and the hub fell on the floor.The patient was fine and not affected by the event.There was no damage noticed to the packaging.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide a correction and additional information in section b5, update section h3, and to provide the completed investigation results.In section b5 of the initial report the date that the additional information was received was inadvertently documented as 19may2020 when the actual date the additional information was received was 04jun2020.One unused 6fr 45cm destination sheath assembly, dilator and the valve assembly was returned in the pouch pack for product evaluation.No other accessory components were returned.Visual inspection revealed that the valve assembly was not connected (screwed) to the sheath hub.No other anomalies were noted.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the investigation results it is likely that the valve assembly became unscrewed from the sheath hub at an unknown time post production, causing the reported event.However, 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 04jun2020.The procedure performed was a leg case.The sheath catheter hub was not attached, and the hub fell on the floor.The patient was fine and not affected by the event.There was no damage noticed to the packaging.Additional information was received on 26jun2020.The valve assembly was separated 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: 10149219
• Report Number: 1118880-2020-00129
• Device Sequence Number: 19393299
• 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): 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 95