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

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: regional value analysis clinician.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.
Event or Problem Description
The user facility reported that the tip of the involved guide wire (that comes with the introducer) embedded/retained in the patient and the end was stretched out.This was discovered when the wire was removed.The tip was confirmed by fluoroscopy to be retained in the patient.No blood loss was reported.The reported event did result in patient injury and/or medical or surgical intervention.There was a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.
Event or Problem Description
Additional information was received on 08 may 2024: the procedure performed was a diagnostic leg angiogram with possible intervention.Resistance was encountered during wire removal.The needle was removed in case the wire was catching on the access needle.The broken tip was not retrieved from the patient.Minimal bleed was reported.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information to sections a1, a2, a3a, a4, a5, a6 and h6: medical device problem code (a).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide a correction to section d4: udi, and the completed investigation results.The sample was not returned for assessment.If the sample is made available in the future, the complaint record will be reopened and updated.The complaint cannot be confirmed for guidewire separation because a sample was not returned for assessment.Without a sample, the exact root cause cannot be determined.The likely root cause is the guidewire caught on the access needle during withdraw and led to the guidewire separation.It is also possible the increased resistance in the vessel during removal contributed to the separation.The pinnacle precision instructions for use (ifu) was reviewed, and it states: "precautions: when using metal needle cannula, do not withdraw the guidewire back into the cannula, as shearing of the guidewire may result." review of the device history record (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 hazard based risk table (hbrt).

• 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: gina digioia ; 950 elkton blvd; elkton, MD 21921 ; 4103927218
• MDR Report Key: 19213359
• Report Number: 1118880-2024-00056
• Device Sequence Number: 18169135
• Product Code: DYB
• UDI-Device Identifier: 00389701010779
• UDI-Public: (01)00389701010779(17)260501(10)0000455819
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2024

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: 05/01/2026
• Device Model Number: N/A
• Device Catalogue Number: 70-5160
• Device Lot Number: 0000455819
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2024
• Supplement Date Received by Manufacturer: 05/08/2024; 07/02/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/03/2024; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2023
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White