MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION GLIDE ACCESS CONVENIENCE KIT; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has beed returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, evaluation code has been referenced in the conclusions.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 while using an ik device once the wire went through the needle, they were not able to remove and lost vessel access.It was reported that there was a positive outcome on the patient's condition.Additional information was received on 9/13/2018: the procedure being performed was a heart catheterization.The case was completed and the procedure outcome was successful.The patient was reported to be stable.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.One 21g needle and 0.018" guidewire was received for product evaluation.Visual inspection revealed remnants of dried bloodlike substance on the guidewire and needle.The guidewire was attempted to be removed from the needle.Excessive resistance was felt upon withdrawal, and the guidewire uncoiled while being pulled back through the needle.No other anomalies such as kinks were noted with the guidewire.Dimensional analysis was carried out on the inner diameter of the needle and outer diameter of the guidewire and were confirmed to meet manufacturer specifications.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation, it is likely that the resistance felt during the separation of the guidewire and needle was likely due to the dried blood observed.However, the exact cause of the reported event cannot be definitively determined.

• Brand Name: GLIDE ACCESS CONVENIENCE KIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 7899120
• Report Number: 1118880-2018-00130
• Device Sequence Number: 1707497
• Product Code: DYB
• UDI-Device Identifier: 00389701007915
• UDI-Public: 0389701007915
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K990705
• 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): 09/21/2018

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: No Information
• Device Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: RSM04
• Device Lot Number: WF16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1