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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3: patient sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.A review of the device history record of the product code/lot# combination was conducted with no findings.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.
Event or Problem Description
The user facility that bleeding was observed at femoral access site of the patient with the involved ik device.A hole was discovered inside of the sheath near the hub.The patient was in stable condition.The procedure outcome ended.The event occurred intra-operative.The patient was not injured, medical or surgical intervention was not required.
Event or Problem Description
Additional information was received on 19 may 2023: the type of procedure performed was a lower leg angiography.The hub was not damaged.The procedure was not completed, procedure concluded when blood was noticed at femoral access site.Ik device was removed, and procedure concluded.Estimated blood loss was less 250 ccs.Additional information was received on 20 jun 2023: according to the physician there was no suture used and and no difficulty with inserting the sheath.
Additional Manufacturer Narrative
One 6 fr sheath was returned for assessment.The sample was subject to visual analysis.There is a crack in the sheath 0.4-0.6 cm from the sheath hub.There are marks in the sheath near the hub that appear to be scratches.The complaint can be confirmed for a crack in the sheath.The exact root cause cannot be determined.It is possible the sheath was inserted into a stent or into plaque in the vasculature that caused the sheath to crack from increased resistance during insertion.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 the risk evaluation is within the predetermined limits in the design failure mode and effects analysis (dfmea).

• 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: 17102104
• Report Number: 1118880-2023-00127
• Device Sequence Number: 19315745
• Product Code: DYB
• UDI-Device Identifier: 00389701007472
• UDI-Public: 00389701007472
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2025
• Device Model Number: N/A
• Device Catalogue Number: RSS602
• Device Lot Number: 0000306246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 06/10/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• 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
• Patient Sex: Unknown