MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE PRECISION ACCESS SYSTEM; 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	08/10/2018
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.This report is for the needle sticking.For difficulty on the wire advancing on the same device and used on the same patient, see mdr 1118880-2018-000102.
Event or Problem Description
The user facility reported that during the procedure the needle in the precision ik kit was unable to accept the wire after access was gained.The needle seemed to be sticking up into the hub so that when access was achieved the wire did not funnel into the needle tube.The wire would go into the hub but would then hit the side of the needle tube.The needle tube appears to not be flush with the hub, allowing the wire to go into the hub but not the needle tube.The patient condition was good.The procedure outcome was a success.There was no other equipment or devices being used with the reported product.Additional information was received on 8/20/18: the procedure being performed was an intravascular procedure via femoral access.The patient was stable after the procedure and when the issue was noted another needle was pulled and used.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device returned date and to provide the completed investigation results.One 21g needle was returned for evaluation.No sheath or dilator were returned.The returned needle was subjected to visual analysis and was examined under microscopy.Which revealed that at the cannula hub junction, there was flash present.Dimensional testing was performed by measuring the inner lumen of the needle hub junction.The inner diameter of the needle was then measured and confirmed to not meet specification.The reported event has been deemed manufacturing related and is being further investigated.

• 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: 7808713
• Report Number: 1118880-2018-00101
• Device Sequence Number: 19199566
• Product Code: DYB
• UDI-Device Identifier: 00389701010472
• UDI-Public: 00389701010472
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018

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: 70-5130
• Device Lot Number: WF16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1