MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION RADIFOCUS INTRODUCER II KIT; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: not provided, maude report.Patient age & date of birth: not provided, maude report.Patient weight: not provided, maude report.Patient ethnicity: not provided, maude report.Patient race: not provided, maude report.Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter establishment name and address: not provided, maude report.Initial reporter name: not provided, maude report.Initial reporter phone number: not provided, maude report.Initial reporter health professional: not provided, maude report.Initial reporter occupation: not provided, maude report.The actual device was not available; therefore, the actual device will not be returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
A maude database search conducted on 30 oct 2022 found a maude report number 15484674.The event description states: while using the catheter in cath lab, the patient moved suddenly and the distal 3/5 of the catheter sheared off and lodged in the patient's iliac artery.The interventionalist had great difficulty retrieving the catheter piece and the patient reached maximum or near maximum radiation exposure.The physician felt it was safe to leave and return to attempt retrieval another day.The retrieval was successful.The patient came into the hospital in extremis, but this catheter event did not exacerbate her clinical condition.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed since the device was not available for evaluation.With the very limited information provided, it is unclear how the sheath shaft could have separated from the hub.In the absence of the device or additional information, the exact root cause cannot be determined.The likely root cause is that the patient's movement caused the sheath to separate.Review of 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 failure mode and effects analysis (fmea).

• Brand Name: RADIFOCUS INTRODUCER II KIT
• 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 ; 6402040886
• MDR Report Key: 15867026
• Report Number: 1118880-2022-00090
• Device Sequence Number: 2492553
• Product Code: DYB
• UDI-Device Identifier: 00389701007472
• UDI-Public: 00389701007472
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K954234
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2022

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: 05/01/2023
• Device Model Number: N/A
• Device Catalogue Number: RSS602
• Device Lot Number: 0000024539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2022
• Supplement Date Received by Manufacturer: 12/11/2022
• Initial Report FDA Received Date: 11/26/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SNARE.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female