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 Consequences Or Impact To Patient (2199)
Date of Event	08/17/2017
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 relevant findings.A search of the complaint file did find two other reports with the involved product code/lot# combination.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Event or Problem Description
The user facility reported that the wire was stripped" after gaining right femoral access through 21g wire provided with kit.It was reported that patient injury did not occur.Additional information was received on 8/24/2017.It was reported that the wire is shearing off.
Additional Manufacturer Narrative
One 0.021" guidewire was returned to for product analysis.The returned component was subjected to decontamination.After decontamination, the guidewire was then subjected to visual analysis where the guidewire was noted to be in two separate pieces.Approximately 0.9620" of the distal end of the core guidewire had fractured and separated from the nitinol core.The two pieces were connected by the unraveled coils of the wire.Microscopic images of the unraveled section and the severed ends were taken.The severed ends appeared bluntly cut and though a sharp edge was used.The complaint could be confirmed for guidewire breakage per the damage observed on the device.However, the cause of this damage appeared to stem from exposing the guide wire to a sharp edge such as would be experienced at the distal tip of the needle.The ifu states "when using metal needle cannula do not withdraw the guidewire back into the cannula, as shearing of the guidewire may result." this may have provided the sharp edge that resulted in the shearing that was observed.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.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• 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: 6865921
• Report Number: 1118880-2017-00074
• Device Sequence Number: 661660
• Product Code: DYB
• UDI-Device Identifier: 00389701010786
• UDI-Public: 00389701010786
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/14/2017

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: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 70-6160
• Device Lot Number: VA25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1