MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE PRECISION ACCESS SYSTEM; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	09/27/2018
Type of Reportable Event	Serious Injury
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 while using a precision device the 021 wire would not pass through the hub into the body of the needle.The reported blood loss was less than 250cc.The patient was reported to be stable.The procedure outcome was successful.There were no other equipment or other devices were used with the reported product.Additional information was received on 9/28/18: the type of procedure being performed was a neuro interventional procedure, pipeline placement for a residual aneurysm.A cook micro puncture kit was opened, access with the cook needle was gained, 018 cook wire was then used to introduce the micro puncture introducer sheath.Then the 021 ss wire was placed followed by the 8fr precision sheath.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the patient identifier and to provide the completed investigation results.One 21g taper tip needle and 0.021" guidewire were returned for product evaluation.No sheath or dilator were returned.There were no anomalies noted with the returned guidewire.Microscopy inspection on the needle revealed that at the cannula hub junction and there was flash present.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.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.

• 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: 7956117
• Report Number: 1118880-2018-00147
• Device Sequence Number: 289284
• Product Code: DYB
• UDI-Device Identifier: 00389701010502
• UDI-Public: 00389701010502
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 70-8130
• Device Lot Number: WC21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 103