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	07/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(b)(4).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 an unknown issue with the valve on the ik, the valve was either leaky or bad.The patient bled heavily while the sheath was in the patient.Additional information was received on august 8, 2019.The case was completed successfully and the patient was reported to be in stable condition.The blood loss was between 300cc and 400cc.The sheath was removed, pressure was held on the wound and another sheath from a different lot was used and the outcome was good.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One 9fr ik introducer sheath and the dilator were returned for product evaluation.Visual inspection revealed that the valve was nested in the sheath hub where the top and bottom of the valve are oriented parallel to the sheath hub.The distal tip of the dilator did not have any damage or gross anomalies.A kink was observed toward the distal end of the shaft of the sheath.The customer confirmed the kink was not present prior to shipping.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the investigation results it is likely that the dilator was inserted off-center into the valve, dislodging the valve from its intended orientation.However, 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: 8910090
• Report Number: 1118880-2019-00219
• Device Sequence Number: 11215605
• Product Code: DYB
• UDI-Device Identifier: 00389701007748
• UDI-Public: 00389701007748
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: RSS906
• Device Lot Number: WK01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ICE CATHETER 8FR SOUND STAR
• Outcome Attributed to Adverse Event: Other; Required Intervention