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

Catalog Number	RSS602
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	04/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was not returned and the evaluation is not yet complete.A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date that this report was sent.For this reason code was used in the conclusions section.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.Actual device not returned.
Event or Problem Description
The user facility reported leakage on the involved device.Follow up communication with the user facility confirmed the following information: a 6fr sheath was leaking badly at the valve during a tavr case; blood loss was less than 250ml; it was reported but not confirmed that the leaking could have been because a 0.035 amplatz stiff wire was left in the valve without the catheter and not centered; (4) the procedure was completed successfully; and the patient's condition was reported as good.
Additional Manufacturer Narrative
The actual device was not available to be returned to the manufacturing facility.Therefore the investigation results are based upon the user facility information and an evaluation of three recent retention samples.No visual anomalies were noted during the visual evaluation.Functional testing confirmed the products met manufacturing specification.The production lot number was not provided by the user facility which prevented a meaningful review of production and complaint records.There is no evidence that this event was related to a device defect or malfunction.The investigation results verified that the retention samples were normal product with no anomalies which would lead to the reported leak.The exact cause of the reported event cannot be definitively determined.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• 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: 5667606
• Report Number: 1118880-2016-00171
• Device Sequence Number: 166897
• Product Code: DYB
• UDI-Device Identifier: 00389701007793
• UDI-Public: 00389701007793
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 05/19/2016

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 Catalogue Number: RSS602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2016
• Supplement Report FDA Received Date: 06/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 61