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

Model Number N/A

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2020

Event Type  malfunction  

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 Description

The user facility reported that the shaft of the involved glidsheath slender sheath was mangled, beyond the entry valve.It was bent and twisted.The case was reported to be in progress.There was no patient injury, medical/surgical intervention required.Additional information was received on 27may2020.The procedure being performed was a left heart catheterization (lhc) via right radial approach.The procedure was completed successfully, normal lhc.The procedure was completed using a second terumo glidesheath.The patient's condition was reported to be good; they were unaffected by the reported issue.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information in section b5, to update section h3, and to provide the completed investigation results.One 6fr glidesheath slender sheath was received for product evaluation, the returned sample contained a sheath, guidewire, dilator, and needle.No other accessory components were returned.Visual inspection revealed that the sheath was damaged at the proximal part of the sheath near the hub.The sheath was observed under a microscope and the sheath was confirmed to be twisted.No other anomalies were noted with the returned components 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.

Event Description

Additional information was received on 19 jun 2020.The product was not used on a patient.There was no torque applied.The product was removed from the package mangled.

• Brand Name: GLIDESHEATH SLENDER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton, md
• MDR Report Key: 10114374
• MDR Text Key: 193649814
• Report Number: 1118880-2020-00115
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701011974
• UDI-Public: 00389701011974
• Combination Product (y/n): N
• PMA/PMN Number: K173831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 60-1060
• Device Lot Number: XN13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 06/03/2020
• Supplement Dates Manufacturer Received: 06/19/2020
• Supplement Dates FDA Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: .035" INQWIRE GUIDE WIRE; 6F CATHETERS; BOSTON SCIENTIFIC EXPO; MERIT 210CM; .035" INQWIRE GUIDE WIRE; 6F CATHETERS; BOSTON SCIENTIFIC EXPO; MERIT 210CM
• Patient Age: 54 YR
• Patient Weight: 91