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	Blood Loss (2597)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted 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.A review of the device history record of the product code/lot# combination was conducted with no findings.
Event or Problem Description
The user facility reported that the radifocus introducer ii kit sheath was inserted in the normal fashion and when the dilator was removed, blood uncontrollably flowed out through the valve.The blood loss was greater than 250cc's.The patient was in stable condition.Additional information was received on (b)(6) 2019.A 9fr terumo sheath was used during a transjugular intrahepatic portosystemic shunt (tips) revision.Once the sheath was inserted into the patient and the inner stylet was removed, blood uncontrollably flowed out from the sheath do to a faulty valve.The blood continued to flow out until the physician was able to change out the sheath; over a wire, for a new one.The procedure outcome was successful.The case was completed in the normal fashion as it normally would be completed with the exception of switching out the 9fr sheath.The blood loss was an estimated 500cc, and there was no treatment done for blood loss besides observation.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in update and to provide the completed investigation results.One 9fr ik sheath was received for product evaluation.No other components were received with the sheath.Visual inspection revealed that the valve could be seen partially dislodged into the hub of the sheath.The valve was then separated from the sheath and examined.The microscopic inspection revealed an off-center indentation on the cross-cut valve.There were no other anomalies noted with the valve.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: RADIFOCUS INTRODUCER II KIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8271249
• Report Number: 1118880-2019-00002
• Device Sequence Number: 1699117
• Product Code: DYB
• UDI-Device Identifier: 00389701007281
• UDI-Public: 00389701007281
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K954234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: No Information
• Device Expiration Date: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: RSS901
• Device Lot Number: WL12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1