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	08/04/2018
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
During product evaluation of the returned precision device there was resistance that was felt when inserting the guidewire into the needle.The patient that was involved with the reported device was in stable condition.The procedure outcome was completed successfully.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.One 21g needle and 0.021" guidewire were returned for evaluation.No sheath or dilator were returned.The returned needle and guidewire were subjected to visual analysis.There were no gross anomalies noted with the returned guidewire.The needle was examined under microscopy.At the cannula hub junction, there was flash.Dimensional testing was performed by measuring the inner lumen of the needle hub junction and the outer diameter of the guidewire.The inner diameter of the needle was then measured which was below manufacture specifications.The outer diameter of the guidewire was measured and was within manufacture specifications.Functional testing was then performed by inserting the guidewire through the needle.The guidewire passed through the needle.However, there was some resistance felt when initially passing the guidewire through the needle.Based on the investigation results the inner diameter of the needle did not meet dimensional specifications and was partially occluded.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: 7873595
• Report Number: 1118880-2018-00129
• Device Sequence Number: 1938752
• Product Code: DYB
• UDI-Device Identifier: 00389701010472
• UDI-Public: 00389701010472
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2018

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: 08/24/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1