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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hematoma (1884); Pseudoaneurysm (2605)

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

Ethnicity - (b)(6).Implanted date: device was not implanted.Explanted date: device was not explanted.Patient height - 165 cm.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.A review of the device history record of the product code/lot# combination was conducted with no findings.

Event Description

The user facility reported that the 5fr pinnacle sheath that was being used during the procedure separated from the hub.The sheath was being used for femoral vein access for an electrophysiology (ep) study case.They stated that no excessive force was being placed upon the product.The hub came off as the sheath was being removed.The patient was brought back the following day for another physician to remove the retained sheath.The patient was in stable condition.The procedure outcome was successful.The estimated blood loss was less than 250cc.Additional information was received on 08feb2021.The separated sheath was left in the patient the day of the procedure.The patient returned the next day with a large hematoma that was treated and at that time the sheath was removed.The blood loss was from the hematoma.The patient developed a pseudoaneurysm which was treated surgically the following day.The complication and removal of the sheath occurred on the same day and then the patient came back the following day with the pseudoaneurysm which was treated at that time.The case was an a fib ablation and an a fib cryo catheter was used during the case.The patient was accessed on the left leg with a 5fr pinnacle and a 9fr pinnacle and on the right leg with a 5fr pinnacle and 12fr sheath for the ablation catheter.

Event Description

Medwatch report was received on (b)(6) 2021.Additional information was received on (b)(6) 2021.The procedure being performed was an electrophysiology (ep) ablation.When the sheath was being pulled, the sheath hub separated from the shaft.The user facility stated that they did not believe the sheath caused the pseudoaneurysm.The patient was eventually taken to surgery and the vascular surgeon closed her up.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information in section b5, to update section h3, to provide the completed investigation results and attach the medwatch report.H6: investigation findings - 114 is based upon the evaluation of user facility information; 213 is based upon evaluation of the unused returned sample.H6 - investigation conclusion - 4310 is based upon evaluation of the user facility information; 67 is based upon evaluation of the unused returned sample.One 5fr introducer kit was returned in a sealed package from the same lot as the reported device for product evaluation.The sealed package contained a sheath, dilator, 3wsc and a guidewire.No other anomalies were noted with the other components during visual inspection.The inner diameter of the tip of the sheath was measured to be 1.73 mm which was within the manufacturer's specifications.The complaint can be confirmed based on the provided information regarding the allegation.Based on the information given, the exact root cause of the event cannot be determined.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.

• Brand Name: RADIFOCUS INTRODUCER II KIT
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11397091
• MDR Text Key: 234617741
• Report Number: 1118880-2021-00027
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701007465
• UDI-Public: 00389701007465
• Combination Product (y/n): N
• PMA/PMN Number: K954234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Model Number: N/A
• Device Catalogue Number: RSS502
• Device Lot Number: 0000004563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 12FR SHEATH; 9FR PINNACLE SHEATH; ABLATION CATHETER
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 82