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

Catalog Number	RSS901
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	11/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned to the manufacturing facility for evaluation.The investigation is currently ongoing.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.The same user facility reported similar events for other devices with the same product code, see mdr's 1118880-2016-00269 and 1118880-2016-00270.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Event or Problem Description
The user facility reported a leak on the involved device.Follow up communication with the user facility confirmed the following information: a leaky valve was reported during a case; and there was no patient injury or medical intervention required.
Additional Manufacturer Narrative
This report is being submitted as follow up number 1 to provide additional information received by the user facility as well as provide the investigation results.(b)(4).The returned sample was visually inspected.The valve was dislodged and off center damage was observed on the valve.An evaluation of the retention sample from the reported and surrounding lots was conducted.There were no visual anomalies noted during visual inspection and all samples met the leak test specification.The valve was present and functioned as intended.A review of the device history record of the product code/lot# combination was conducted with no relevant findings.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be definitively determined, based on the available information it is likely that the dilator was inserted off center which caused the valve to dislodge resulting in the leakage reported.The potential for such an event is addressed in the instruction-for-use (ifu) with statements such as the following: "insert the dilator into the valve center of sheath.Forced dilator insertion missing the valve center may cause valve damage, resulting in blood leakage." all available information has been forwarded to the manufacturing facility for appropriate tracking, trending and follow up.
Event or Problem Description
Additional information provided on 12/7/2016 confirmed the following; the leakage was found pre-treatment and the device was not used on the patient; and the sheath was replaced with another sheath.
Additional Manufacturer Narrative
(b)(4).

• 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: 6149090
• Report Number: 1118880-2016-00271
• Device Sequence Number: 53087
• Product Code: DYB
• UDI-Device Identifier: 00389701007281
• UDI-Public: 00389701007281
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2016

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 Expiration Date: 12/31/2018
• Device Catalogue Number: RSS901
• Device Lot Number: UH27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/07/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 01/05/2017; 04/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR