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	01/27/2020
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 glidesheath slender was inserted into right radial artery without incident.A 5fr tig catheter was inserted through the sheath over a.035 j wire to the descending aorta without incident.The wire was removed and subsequent imaging of both right and left coronary arteries was accomplished again without incident.After which it was noticed that the sheath was leaking at the junction of the hub and the sheath tubing material.The leaking did not involve the valve.The blood loss was less than 10cc.The sheath was removed, and a tr band was placed over the puncture site without incident.Patient condition was reported to be excellent, no issue.The procedure outcome was excellent.There was no patient injury/medical or surgical intervention required.Additional information was received on 06feb2020.The location was on the sheath tubing just below the valve/hub area.The patient was in stable condition.The procedure was a left heart catheterization via a right radial approach.
Additional Manufacturer Narrative
One 6fr glidesheath slender sheath was returned for product evaluation.Visual inspection of the sheath revealed a major kink was noted on the shaft at the hub.It was also noted that several dents and kinks were along the shaft of from the hub to the tip.A blood like substance was noted between the junction of the hub and the sheath shaft.Leak testing was attempted; however, it could not be performed because of the damage noted along the shaft of the sheath.The sheath could not be properly fixed inside a 12 fr balloon to be properly leak tested.However, during decontamination, the sheath was flushed with fluid to remove the blood-like substances and no evidence of leaking was noted at the sheath hub.The crosscut valve was dissected to observe the sheath inner lumen under microscope and no damage was noted.The caulking pin was firmly seated inside the inner lumen and there were no gaps or damage noted around the caulking pin.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively 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
• MDR Report Key: 9771318
• Report Number: 1118880-2020-00057
• Device Sequence Number: 14046574
• Product Code: DYB
• UDI-Device Identifier: 00389701012070
• UDI-Public: 00389701012070
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173831
• 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): 02/28/2020

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: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 80-1065
• Device Lot Number: XL25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/02/2020
• 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: 0.035 J TIP WIRE; 5FR TIG CATHETER