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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during an animal study, while attempting to get access in the femoral artery, there was resistance inserting the wire through the needle.When removing the wire there was also some resistance.Once the wire was out of the body, it was noticed that the wire tip was sheared off.The residual wire was seen on ultrasound and fluoroscopy.The wire appeared outside of the artery (in the tissue track) on ultrasound.A 5fr pinnacle precision was used.The vessel size was initially approximately 5mm.The vessel was healthy and without disease.The procedure outcome was successful, and the patient was stable.
Additional Manufacturer Narrative
Age & date of birth: patient is an animal (pig).Patient sex: patient is an animal (pig).Weight: patient is an animal (pig).Ethnicity: patient is an animal (pig).Race: patient is an animal (pig).Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: fcs 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# combination was conducted with no findings.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One ik precision nitinol guidewire was returned for product evaluation.Visual inspection was performed.The guidewire was missing its tip, had a broken segment separated from the main body, and had a region of open coil.Dimensional testing was performed.The overall length was measured to be 42.6cm, the open coil region was 37.4-39.6cm from the stiff end, the breakage occurred at 40.7cm from the stiff end, and the broken segment was 0.8cm long.The outer diameter could not be measured due to the state of the device.The complaint can be confirmed for guidewire separation based on the state of the returned device.The exact root cause cannot be determined.He likely root cause is that the guidewire experienced relative motion back through the needle which caused it shear.Review of dhr showed there were no issues noted during manufacture of the product that could have contributed to this complaint condition.Currently no action is recommended since this risk evaluation is within the predetermined limits in the fmea.

• 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: 13232519
• Report Number: 1118880-2021-00229
• Device Sequence Number: 14554214
• Product Code: DYB
• UDI-Device Identifier: 00389701010809
• UDI-Public: 00389701010809
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

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: 02/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 70-8160
• Device Lot Number: 0000063336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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 Sex: Unknown