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

Model Number N/A

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2020

Event Type  malfunction  

Manufacturer Narrative

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/ potential lot# combination was conducted with no findings.

Event Description

The user facility reported that the during room prep for a femoral angiogram and prior to the patient being brought into the room, during opening of the ik device package it was noted that the femoral sheath was bent.A new sheath was opened and prepped, and the procedure went ahead without issue.There was no patient injury, medical/surgical intervention required.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in the d10 section and to update the h3 section.In the initial report the d10 section was advertently left blank.A follow up report will be submitted once the investigation is complete.

Manufacturer Narrative

This report is being submitted as follow up no.2 to update section h3, and to provide the completed investigation results.One 6fr introducer sheath, dilator and the packaging pouch were received for product evaluation.It was noted that the sheath and dilator were received mated together with the dilator inserted into the sheath from the sheath tip instead of the hub.The dilator and sheath for ik products are originally packaged this way.The components were still mated together, the sheath and dilator were subjected to visual analysis.A bend was noted mid-shaft of the two components mated together.The dilator was removed from the sheath and a bend was noted at 5 cm from the dilator hub.The bend noted on the sheath was 6 cm from the sheath hub.It was also noted that the packaging pouch had been opened and it was found to be crumpled and folded with red writing on it.Based on the provided information and investigation results there is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that mishandling of the package, prior to usage, likely caused the damage noted on the sheath and dilator.Because the packaging pouch was received opened and crumpled, the cause cannot be confirmed.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: RADIFOCUS INTRODUCER II KIT
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton, md
• MDR Report Key: 10088652
• MDR Text Key: 192043538
• Report Number: 1118880-2020-00110
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701007649
• UDI-Public: 00389701007649
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2021
• Device Model Number: N/A
• Device Catalogue Number: RSS604
• Device Lot Number: XG12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1