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

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the doctor experienced trouble while getting the guidewire down with the pinnacle precision device involved.When the doctor was able to get the wire down, a picture was taken, and metal fragments were seen.The guidewire was pulled out and the guidewire had unraveled.The patient was in stable condition.The procedure outcome was successful.There was no equipment or other devices used with the above product.There was no patient injury/medical or surgical intervention required.Additional information was received on 23december2021: the procedure performed was a lower extremity angiography/revascularization (le angio/revasc).A metal fragment remained in the patient.The patient will be having surgery in the next couple of weeks and the fragment will then be removed.The procedure was completed once the wire was removed.No other devices were used after removing the unraveled wire.
Additional Manufacturer Narrative
Weight: additional information: 55.3 kgs.Implanted date: device was not implanted.Initial reporter occupation: manager.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.A review of the device history record of the product code/lot number combination was conducted with no findings.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information to section b3, b5, e4, to update section e3, h3, to attach medwatch #(b)(4) and to provide the completed investigation results.One 5fr ik precision guidewire and needle were returned for product evaluation.The guidewire was subject to visual analysis.An open coil region was observed at the end of the wire.The overall length of the guidewire was measured to be 42.3cm, and the open coil region was 37.5cm from the stiff end to the end of the guidewire.The specification for the guidewire length is 42.8 to 44cm.The inner diameter of the needle cannula was then measured to be (b)(4)", and the specification is (b)(4)".The complaint can be confirmed for guidewire separation/break due to the state of the returned device and because the overall length of the device was shorter than the specification.The likely root cause for this event was that the needle id was below specification and caused the guidewire to snag on the needle during insertion and extraction of the guidewire.A nonconformance was issued to address the nonconforming needle.
Event or Problem Description
Additional information was received on 31 jan 2022: terumo medical received an fda medwatch report # (b)(4)." the event description states: "tip of wire for the sheath sheared off in the patient and unraveled.".

• Brand Name: PINNACLE PRECISION ACCESS SYSTEM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: mary o'neill ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 13261259
• Report Number: 1118880-2021-00228
• Device Sequence Number: 17309197
• Product Code: DYB
• UDI-Device Identifier: 00389701010786
• UDI-Public: 00389701010786
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K111606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 70-6160
• Device Lot Number: 0000055580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White