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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2020
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 destination sheath hub was broken before it was removed from the package.There was no patient injury, medical/surgical intervention required.Additional information was received on 13feb2020.It was not used in the procedure room with a patient.It was being put onto the prep table.The hub was the component that was broken.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One 6fr destination sheath and dilator were received for product evaluation.Visual inspection revealed that both components were shaped into a u-shape.The hub assembly was subjected to visual analysis.The three-way stopcock (3wsc), which is a part of the hub assembly, was found to be broken off at the connection to the side tube and was not returned for evaluation.There was no damage noted on the sheath hub.The breakage is on the 3wsc body, midshaft of the center of the body and the connection to the side tube.A fragment of the 3wsc body was still connected to the side tube.The sheath was flattened from 20.5 cm to 33 cm from the tip.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that improper handling of the package caused the damage noted on the sheath and the 3wsc.However, 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: 9793658
• Report Number: 1118880-2020-00005
• Device Sequence Number: 2288781
• Product Code: DYB
• UDI-Device Identifier: 00389701007793
• UDI-Public: 00389701007793
• 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): 03/05/2020

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: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: RSP02
• Device Lot Number: XC20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1