MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION GLIDESHEATH SLENDER; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	09/04/2019
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
Terumo medical received a voluntary health (b)(6) report, mdip report number (b)(4).The event description states: "one way valve on sheath defective.Blood was leaking out of sheath and needed to be removed and replaced after initial insertion for cardiac catheterization procedure." additional information was received 10september2019: there was no patient harm.Blood loss was minimal, less than 250cc's as they switched out the device for a second glidesheath slender and completed the procedure as intended.The patient condition was stable.There was no additional equipment or other devices used with the reported device.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update the h3 section and to provide the completed investigation results.One 6fr glidesheath slender sheath was received for product evaluation.Visual inspection revealed no damage on the device.The sheath was then subjected to leak testing.The distal end of the sheath was inserted into a 12 fr balloon.The distal end of the balloon was connected to a controlled air supply system.The 3-way stopcock (3wsc) was closed, and the air pressure was increased to 4.3 psi.The setup was submerged underwater for approximately 30 seconds.No air bubbles were observed.A dilator for investigational purposes was then inserted into the sheath.This assembly was submerged in water, and no bubbles were detected for 30 seconds.The sample passed the leak test per guidelines.To check for damage at the crosscut valve, the valve was dissected and observed under microscope.Damage was observed at the center of the crosscut valve.No gross anomalies or damage was seen on at the sheath inner lumen hub.Based on the provided information and investigation results there is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that that off-center insertion of the dilator caused the crosscut valve damage.However, the exact cause of the reported event cannot be definitely determined based on the available information.

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 9150452
• Report Number: 1118880-2019-00242
• Device Sequence Number: 2782144
• Product Code: DYB
• UDI-Device Identifier: 00389701011134
• UDI-Public: 00389701011134
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K152173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 20-1060
• Device Lot Number: XE17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/03/2019
• 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