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

Model Number	N/A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not implanted.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 a wire would not advance through the needle included in the 16cm slender kit.There was normal blood flow once the radial artery was accessed but the wire would not pass through the needle.A new kit was opened and used successfully.The patient was stable.The procedure outcome was successful.There was no other equipment or devices being used with the reported product other than what came in the kit.Additional information received on (b)(6) 2018: the procedure being performed was a diagnosis coronary angio that turned interventional.Then an interventional guide and such were inserted once successful access was obtained.Additional information received on (b)(6) 2018: the procedure being performed was a diagnosis coronary angio that turned interventional.Then an interventional guide and such were inserted once successful access was obtained.
Additional Manufacturer Narrative
Weight - 67.45kg.One 6fr glidesheath slender was returned for product evaluation.The device was returned along with guidewire, dilator, and needle without protector.Visual inspection revealed no anomalies were noted with either the needle or the guidewire.The guidewire was placed under microscopy and each end was examined.The floppy end was verified to be normal.The needle hub was also inspected under a microscope and the entry of the cannula were verified to be clear of any flash or obstructions.Functional testing was conducted on the returned guidewire which was inserted into the needle and passed through its length without any difficulties.No anomalies were noted during insertion or withdrawal.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, the returned device was the normal product.However, the exact cause of the reported event cannot be definitively determined.

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8166284
• Report Number: 1118880-2018-00198
• Device Sequence Number: 1903046
• Product Code: DYB
• UDI-Device Identifier: 00389701012117
• UDI-Public: 00389701012117
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 80-1660
• Device Lot Number: WH18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 67