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	Hematoma (1884)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A3b: gender: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: cath lab clinical supervisor 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 sheath broke inside of a patient.It was retrieved and saved.Additional information was received on 17apr2024: the procedure being performed was a left heart diagnostic angio via right femoral access.When attempting to remove the sheath they pulled until it separated.All pieces of sheath were removed in the cath lab.The patient was sent to surgery for endoractomy patch and hematoma evacuation.Size of hematoma was not received.No history of femoral closure at this hospital.Growing shot taken, however, not available at this time.Reported blood loss was less than 250ml.The patient was stable.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d4 udi and to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted, however, a photo was provided by the account.The complaint can be confirmed for a sheath separation based on the photo provided by the account.Without a sample, the exact root cause cannot be determined.The likely root cause is the user encountered resistance during withdraw from plaque or a spasm that 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 hazard based risk table (hbrt).

• 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: 19288710
• Report Number: 1118880-2024-00071
• Device Sequence Number: 12548510
• Product Code: DYB
• UDI-Device Identifier: 00389701007472
• UDI-Public: (01)00389701007472(17)260201(10)0000413738
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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: 02/01/2026
• Device Model Number: N/A
• Device Catalogue Number: RSS602
• Device Lot Number: 0000413738
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2023
• 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: Required Intervention; Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White