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

Model Number	N/A
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ethnicity - requested but not provided.Race - requested but not provided.Implanted date: device was not implanted.The actual device has not been returned to the manufacturing facility 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 relevant findings.A search of the complaint file did not find any other report with the involved product code/lot# combination.
Event or Problem Description
The user facility reported that the dilator separated from dilator hub.It was reported that the patient condition was satisfactory.It was reported that the procedure outcome was completed successfully.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.With no return of the actual device the exact cause of the reported event cannot be definitively determined.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the device return date and the completed investigation results.One 4fr ik device was returned for evaluation.The returned device was decontaminated per terumo medical corporation's policies and procedures.After decontamination, the device was subjected to visual analysis.There were no anomalies noted with the 4fr sheath.The dilator was returned in two pieces.The red hub had separated for the dilator sheath.Microscopic images were taken of the fracture point.The fracture point appeared as a diagonal plane with jagged edges.This is indicative of a torsional force.The complaint could be confirmed for dilator damage as the dilator was returned with the hub detached.No conclusion can be drawn as to the cause of the break in the dilator.Past historical complaints and bench to testing have shown excessive forces can lead to hub separation.The dilator is 100% inspected as part of the manufacturing processes where this anomaly would have been identified.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: 7052244
• Report Number: 1118880-2017-00091
• Device Sequence Number: 1068543
• Product Code: DYB
• UDI-Device Identifier: 30389701007220
• UDI-Public: 30389701007220
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2017

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: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: RSS402
• Device Lot Number: VA11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 12/04/2017; 01/31/2018
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 12/19/2017; 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 79