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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	08/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 involved destination was inserted over a 260cm.035 glidewire advantage ga3502.The sheath was inserted without incident and when the dilator was removed, excessive leakage was noticed coming out of the cross-cut valve.The md inserted a dilator several times to "reset the valve".They then removed the valve and replaced it with a valve from 54-74501.The access was the right groin.The case was completed without incident.Blood loss was reported to be less than 20cc.There was no harm to the patient.The procedure was completed without incident and the patient left the facility with no complications.The outcome of the procedure was excellent.Additional information was received on 22aug2019.The procedure was a left leg intervention and access was obtained via right femoral artery.The sheath was introduced via right and over the iliac bifurcation to the left leg.
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 8fr destination sheath hub was returned for product evaluation.Visual inspection revealed damage at the sheath hub.To check for damage at the sheath hub, the sample was viewed under microscope and the valve was seen to be partially dislodged in the sheath hub toward the distal end of the hub.The cross valve was not in its intended orientation; one side of the valve was pushed downward into the sheath hub.The dilator tip was not returned and could not be analyzed for possible tip damage.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 dilator was inserted off center and moved the cross valve from its intended position.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: RENAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 9009328
• Report Number: 1118880-2019-00241
• Device Sequence Number: 2477509
• Product Code: DYB
• UDI-Device Identifier: 00389701009414
• UDI-Public: 00389701009414
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K012854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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: 54-84501
• Device Lot Number: XC20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 260CM .035 GWA - GA3502