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 Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One.021" guidewire and 21g needle were received for product evaluation.No other components were returned.After decontamination, the returned components were subjected to visual analysis.The distal "floppy" end of the guidewire appeared partially uncoiled.The core material was intact but at least one of the coils appeared to have been sheared off the core causing the uncoiling.The distal tip of the coils had a blunt appearance.The needle was inspected under microscopy for any damage.No damage was noted to the needle.A review of the device history record of the product code/lot# combination was conducted with no findings.Ifu rfin0073 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.The exact cause of the reported event cannot be definitively determined based on the available information.However, past complaint history has found shearing, similar to what was found on the returned device, can occur from the user withdrawing the guidewire through the needle.
Event or Problem Description
The user facility reported the wire broke and came apart going through needle.The estimated blood loss was less than 250 cc.The procedure was successful and the patient was reported to be fine.Additional information was received on january 24, 2018.There were no other devices or equipment used with the ik kit.The broken wire was retrieved.

• 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: 7251130
• Report Number: 1118880-2018-00002
• Device Sequence Number: 158364
• Product Code: DYB
• UDI-Device Identifier: 00389701010786
• UDI-Public: 00389701010786
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Type of Report: Initial
• Report Date (Section B): 02/08/2018

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: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 70-6160
• Device Lot Number: VK23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1