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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the involved ik device sheath broke in half during exchange.Half of the sheath got stuck in the patient's inferior vena cava (ivc), requiring ir foreign body removal.The event occurred intra-operative.Additional information was received on 17 apr 2024: the type of procedure being performed was an atrial fibrillation ablation.The user did encounter resistance during removal.Estimated blood loss was less than 250 cc.Patient is in stable condition.The wire was exchanged to a biosense webster vizigo sheath.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3a: sex: requested, not provided.A3b: gender: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: not provided for animal use.A6: race: not provided for animal use.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.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide additional information in section and to provide the completed investigation results.The actual device is not available for return; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for sheath separation because a sample was not returned for assessment.Without a sample, the exact root cause cannot be determined.Field clinical was informed about the sheath separation and said that it is unlikely that the sheath would reach the ivc from the femoral access site as the ik (introducer kit) sheath is short.It is possible a spasm occurred at the femoral access site that caused the sheath to separate during withdrawal.In the absence of details regarding the size of the artery and the access site, no conclusions can be made regarding the cause of the alleged sheath separation.Review of dhr (device history record) 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 hbrt (hazard based risk table).
Event or Problem Description
Additional information was received on 30 may 2024: the access site was through the right femoral artery.

• 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 ; 4103927218
• MDR Report Key: 19274953
• Report Number: 1118880-2024-00057
• Device Sequence Number: 6358271
• Product Code: DYB
• UDI-Device Identifier: 00389701010779
• UDI-Public: 00389701010779
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 05/08/2024

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: RSS801
• Device Lot Number: 0000506845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2024
• 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