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

Model Number	N/A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2019
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 doctor felt some resistance with the glidesheath slender as the wire was put in the needle.The wire passed a little further and then would not advance.The doctor looked under fluoro and elected to remove the wire instead of pushing it any more.As the doctor pulled back, the doctor noticed that the front of the wire was not moving the same amount as the back of the wire.The image on the fluoro showed the distal tip of the wire was thinner and longer than it was originally.The doctor removed the needle and wire together.The patient had no issues.The heart catheterization was performed from alternate access site.The patient was unaffected by the product issue and was in stable condition.The patient was discharged.The left heart catheterization procedure was successful.There were no other devices or equipment used with the product.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the details in the h10 that was supposed to be in the h10 section of follow up no.1.In follow up no.1 the h10 section should have stated that "this report is being submitted as follow up no.1 to correct the b4 date.In the initial report it was reported that the date of this report was 12-dec-2019 however the correct date is 12-feb-2019." the investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
This report is being submitted as follow up no.3 to update the and to provide the completed investigation results.One 6fr glidesheath slender guidewire and a needle were received for evaluation.Visual inspection revealed that the distal tip of the guidewire had uncoiled to the point where the coil was fused with the core of the guide wire.The stiff end measured to be 0.0204" which was within the manufacturer specifications.Under microscopy of the unraveled sections and points of fracture were visualized, the fracture point appeared bluntly cut.No gross anomalies were noted with the needle.The needle hub was inspected under a microscope and the entry and exit of the cannula were verified to be clear of any flash or obstructions.The inner diameter of the needle was measured 0.0230" using pin gauges which met the manufactures specification.Ifu states: "do not withdraw the guide wire through the cannula, as shearing of the guide wire may result." there is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, is likely that the guidewire shearing may occur if the guidewire was withdrawn through the needle.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• 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: 8332062
• Report Number: 1118880-2019-00021
• Device Sequence Number: 16552810
• Product Code: DYB
• UDI-Device Identifier: 00389701011332
• UDI-Public: 00389701011332
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/12/2019

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: 02/29/2020
• Device Model Number: N/A
• Device Catalogue Number: 50-1060
• Device Lot Number: WD07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 02/15/2019; 02/15/2019; 03/06/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 02/15/2019; 02/15/2019; 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR