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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has been received 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.A search of the complaint file did not find any other report with the involved product code/lot# combination.
Event or Problem Description
The user facility reported that the dilator broke at hub upon flushing prior to being used on the patient.There was no patient involvement.It was reported that the patient is in good condition.The procedure outcome was successful.
Additional Manufacturer Narrative
This report is being submitted to provide the completed investigation results.One used 6fr ik sheath was returned for evaluation.The device was decontaminated then subjected to visual analysis where blood like substance was observed on the returned device.The sheath and dilator were properly mated.An attempt was made to remove the dilator from the sheath.When the hub of the dilator detached from the hub of the sheath, the shaft of the dilator was no longer found to be attached to the hub of the dilator.Microscopy was used to analyze the severed point.There was a jagged appearance to the severed point.There was deformation of the material of the dilator sheath.The complaint could be confirmed for dilator shaft damage as the hub of the dilator separated from the shaft.The jagged edges of the severed point indicate that the dilator likely detached under forces of tension.No conclusion can be drawn at this time as to the cause of the force that led to the detachment.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with terumo medical corporation specifications and procedures.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.

• 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: 7053323
• Report Number: 1118880-2017-00090
• Device Sequence Number: 18853512
• Product Code: DYB
• UDI-Device Identifier: 30389701010787
• UDI-Public: 30389701010787
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2017

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: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 70-6160
• Device Lot Number: VC15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1