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)
Type of Reportable Event	Malfunction
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.For this reason, evaluation code has been referenced in the conclusions.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 the physician experienced difficulty when attempting to gain femoral access with a precision device.It was reported that the wire broke apart during insertion of the sheath.The device was removed from the patient.There were no parts of the device remaining in the patient.The patient had a large panus.The patient is in stable condition.The procedure outcome was successful.Additional information was received on 6/5/2018: it was reported that there was no blood loss.The device came out of body when the entire system was removed.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the date.In the first follow up report the date was advertently left bank.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.One 0.021" guidewire was returned in two pieces for product evaluation.No other accessory components were returned.The two sections of guidewire were measured.The section containing the distal "floppy" end measured 22" from the end of the unraveled section of the wire which measured 1.454".The proximal section measured 26" from the unraveled section of the wire which measured 0.7071".Microscopy of the unraveled sections was done to visualize the uncoiled strand of each of the unraveled sections.The complaint can be confirmed for guidewire breakage.Past complaint history has indicated that withdrawing the guidewire into the cannula of the needle can result in shearing of the guidewire which the ifu caveats against.No definitive conclusion can be drawn as to the cause of the guidewire breakage; however, the complaint description indicates patient physiology was a factor as the patient had a large panus and there was difficulty inserting the sheath over the guidewire which then resulted in guidewire breakage.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: 7605429
• Report Number: 1118880-2018-00032
• Device Sequence Number: 16679772
• Product Code: DYB
• UDI-Device Identifier: 30389701010480
• UDI-Public: 30389701010480
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup,Followup
• Report Date (Section B): 06/15/2018

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: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 70-6130
• Device Lot Number: WD14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 05/30/2018; 07/02/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 07/11/2018; 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1