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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not implanted.Device was not explanted.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record of the product code/lot# combination was conducted with no findings.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.
Event or Problem Description
The user facility reported that after taking out the dilator of the sheath of the involved glideseath slender, blood was pulsating back through the valve as if the valve was not there.The doctor kept his thumb over the valve so that the bleeding would stop.The doctor then put a wire in quickly to exchange for a different sheath.After manipulating the wire, the valve seemed to get in position and the leakage stopped.The estimated blood loss was less than 250cc.There was no harm to the patient.The procedure was finished.Additional information was received on october 1, 2018.The procedure being performed was a radial left heart catheterization.The doctor did not change the sheaths, he wiggled it, while he had the wire in, and it stopped bleeding (it was believed that the valve realigned itself).Once bleeding was down to trickle, he proceeded with the rest of case.The patient was stable and the procedure was finished successfully.Additional information was received on october 3, 2018.After manipulating the wire, the valve seemed to get into position, and stopped the leakage.The initial sheath was kept in.Wires, balloons , and catheters were used the rest of the case.

• Brand Name: GLIDESHEATH SLENDER NITINOL
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 7952451
• Report Number: 1118880-2018-00146
• Device Sequence Number: 16526831
• Product Code: DYB
• UDI-Device Identifier: 00389701011981
• UDI-Public: 00389701011981
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142183
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

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: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 60-1065
• Device Lot Number: WG06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1