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	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.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 or Problem Description
The user facility reported that during an afib case where they are using an 8fr ultrasound ice catheter.They noticed an issue when they hook up the extension side arm for act.The sheath leaked when they drew back, they noticed air in the side port line.It was reported that they saw possible tears in the hemostatic valve.The patient was in good condition.The procedure outcome was a success.The blood loss was less than 250cc's.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update the h3 section and to provide the completed investigation results.Five unopened 9fr introducer sheaths were received for product evaluation.Two samples were subjected to visual inspection and no damage was seen on the devices.Supplier quality and operations engineering, along with personnel from manufacturing, were consulted to investigate the functionality of the device.It was determined that the device should be subjected to leak testing per the incoming inspection process.Both samples passed leak testing.Each sheath was then subjected to leak testing.The distal end of the sheath was inserted into a 12 fr balloon.The distal end of the balloon was connected to a controlled air supply system.The 3-way stopcock (3wsc) was closed, and the air pressure was increased to 4.3 psi.The setup was submerged underwater for approximately 30 seconds.No air bubbles were observed.A dilator for investigational purposes was then inserted into the sheath.This assembly was submerged in water, and air bubbles were observed for one sample and not the other.The dilator was re-inserted into the sheath that had air bubbles and the device was submerged in water again, no air bubbles were seen.It is possible the dilator was inserted-off center during the initial run of this leak test.To check for damage at the crosscut valve, the valve was dissected and observed under microscope.No damage was observed on the crosscut valve.The distal tip of the dilator had minor damage/deformation after being inserted into the sheath, prior to insertion there was no damage seen on the dilator tip.The sheath inner lumen did not have any damage or gross anomalies.Reviewed introducer kit ifu: "insert the dilator into the valve center of the sheath.Forced insertion of the dilator which misses the center of the sheath valve may cause damage, and result in blood leakage." based on the provided information and investigation results there is no evidence that this event was related to a device defect or malfunction.The investigation results verified that the returned unused devices were of the normal product.However, the exact cause of the reported event cannot be definitely 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: 9150451
• Report Number: 1118880-2019-00270
• Device Sequence Number: 16876094
• Product Code: DYB
• UDI-Device Identifier: 00389701007502
• UDI-Public: 00389701007502
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: RSS902
• Device Lot Number: XE03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 10/28/2019
• 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: 8FR ULTRASOUND ICE CATHETER