MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE PRECISION ACCESS SYSTEM; 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	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not implanted.The actual device has not 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.See mdr report no.1118880-2018-00065 for a second device with the same product code/lot number combination that was used on the same patient that is being reported in this report.
Event or Problem Description
The user facility reported that the needle leaks from the side of the hub during a popliteal arterial access when using the ik device.When it is attached to a syringe the saline squirts out from the side.The procedure outcome was good.The patient was reported to be in good condition.Additional information was received on 7/3/18: the procedure was completed using the device.The doctor discovered the leak while attempting to inject lidocaine through the access needle into the subcutaneous tissue.Additional information was received on 7/17/18: the syringe was a 10ml b&d syringe with lidocaine.The plastic hub of the needle not the needle itself was leaking.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date.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.2 to update and provide the completed investigation results.One 21g needle was returned for evaluation.Visual inspection no anomalies.Functional testing was conducted.A syringe full of water was attached to the needle.When the needle was flushed, water sprayed from the hub at an angle.Microscopic images of the hub revealed deformation of the hub.An indentation was present that created a channel for water to spray out of the hub.Terumo is currently investigating the reported event to determine the exact cause.

• Brand Name: PINNACLE PRECISION ACCESS SYSTEM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 7705842
• Report Number: 1118880-2018-00066
• Device Sequence Number: 732114
• Product Code: DYB
• UDI-Device Identifier: 00389701010885
• UDI-Public: 00389701010885
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2018

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: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 70-5165
• Device Lot Number: WF23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 07/25/2018; 08/20/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 07/26/2018; 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10ML B&D SYRINGE; LIDOCAINE
• Patient Age: 69 YR
• Patient Weight: 107