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	08/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has 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.
Event or Problem Description
The user facility reported that during the initial entry of the wire into the needle using a precision device, the wire started coming apart and the coils stretched apart.The physician did not remove and reinsert multiple times and it occurred right away.Another wire was used successfully after the issue was noted.The patient was fine and stable.The procedure outcome was successful.No other equipment or devices were being used with the precision kit.Additional information was received on 8/22/2018: the procedure being performed was a run-off / peripheral angio.Access was on the right femoral artery.
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 guidewire was returned for product evaluation.No other accessory components were returned.The proximal section which maintained its integrity measured 37.5 cm.The coils on this portion did not unravel.The proximal section then onwards showed that significant portions of the wire were uncoiled.The ifu states, "when using metal needle cannula do not withdraw the guidewire back into the cannula as shearing of the guidewire may result." there is no evidence that this event was related to a device defect or malfunction.Based on the complaint description it states that the physician inserted the guidewire into the needle; it is likely that the introduction of a sharp obstruction or unintended backward motion led to the unraveling may have caused the reported event.However, 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: 7837823
• Report Number: 1118880-2018-00106
• Device Sequence Number: 1536058
• Product Code: DYB
• UDI-Device Identifier: 00389701010779
• UDI-Public: 00389701010779
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/31/2018

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: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 70-5160
• Device Lot Number: WC21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 88