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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2019
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 there was a crimped area noted on the shaft of the ik sheath.This was discovered prior to using or attempting to use the device.A new sheath was used to complete the case.There was no patient injury.The procedure outcome was successful.Additional information was received on 10oct2019.The procedure was a heart catheterization / percutaneous coronary intervention (pci).The patient was in stable condition.
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 6fr introducer sheath and dilator were returned for product evaluation.Visual inspection revealed that no damage was seen on either component.The sheath shaft was inspected under microscope and a very small bend was observed on the shaft.Dimensional testing was performed.Measurements were taken of the sheath shaft and the diameter measured at 2.641 inches which is within the manufacturer specification.Measurements were also taken of the dilator shaft and the diameter measured at 2.093 inches which is within the manufacturer specification.Based on the provided information and investigation results, there is no definitive 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: 9251765
• Report Number: 1118880-2019-00303
• Device Sequence Number: 13960908
• Product Code: DYB
• UDI-Device Identifier: 00389701007472
• UDI-Public: 00389701007472
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 10/29/2019

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: 12/31/2019
• Device Model Number: N/A
• Device Catalogue Number: RSS602
• Device Lot Number: XH17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 76