MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not implanted.The actual device has been returned to the manufacturing facility 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 they were unable to insert the locator with the involved angio-seal device.The following information was provided by the user: the valve would not stay secure on the sheath.The sheath was never inserted into the patient.The malfunction was noticed when prepping the sheath and therefor never used.Another 8 fr destination was opened and used successfully.There was no blood loss and the patient was stable.There were no other devices or equipment used with the reported product.
Additional Manufacturer Narrative
This report is being submitted to provide the completed investigation.One used 8fr peripheral destination device was received for product.After decontamination, the returned sheath and dilator were subjected to visual analysis.The luer of the crosscut valve assembly did not appear secured to the hub of the sheath.There was only approximately one turn of the luer onto the hub.By rotating the assembly clockwise, the luer fit became more secure.Tensile force was then applied and the valve remained attached to the hub of the sheath.A slight quarter turn in the counterclockwise position, loosen the valve enough to replicate the user's issue.There were no other visual anomalies noted with the device.Microscopic pictures were taken of the luer to observe if any additional damage had been sustained which allowed the luer to loosen.No anomalies were found.There is no 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.However, based on the condition of the returned device, it does not appear that the user followed the ifu instructions to ensure that the valve and the sheath are tightly connected.A quarter turn in the counterclockwise direction easily dislodged the valve.The ifu states "ensure that the valve and the sheath are tightly connected.".

• Brand Name: PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 7103712
• Report Number: 1118880-2017-00093
• Device Sequence Number: 19141101
• Product Code: DYB
• UDI-Device Identifier: 00389701009414
• UDI-Public: 00389701009414
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2017

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: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 54-84501
• Device Lot Number: UN16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1