MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION RENAL GUIDING SHEATH; INTRODUCER CATHETER

Catalog Number	RSR04
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	04/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The actual device was returned to the manufacturing facility for evaluation.Visual examination of the valve under microscope revealed an off-center anomaly on the cross cut valve.Valve leakage test was conducted without stressing the valve.A leak was noted.The dilator was partially inserted through the valve, then submerged and tested.No leakage was observed.The dilator was withdrawn and the sheath submerged and tested and again no leakage was observed.The valve was then disassembled from the sheath and closely examined under magnification and an off-center anomaly was confirmed to be present on the valve.Retention samples from the reported product code/lot# combination as well as from the surrounding lots was conducted.There were no visual anomalies noted and valve leakage testing confirmed the products met manufacturing specification.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.The investigation results verified that the retention samples were normal product.The returned sample failed the leak test which confirms the reported complaint.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.
Event or Problem Description
The user facility reported leakage on the involved device.Follow up communication with the user facility confirmed the following information: excessive leaking out of cross-cut valve; blood loss was less than 250ml; the procedure was completed successfully; and the patient was reported as in good condition.

• Brand Name: RENAL GUIDING SHEATH
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 5654006
• Report Number: 1118880-2016-00167
• Device Sequence Number: 21074
• Product Code: DYB
• UDI-Device Identifier: 00389701007335
• UDI-Public: 00389701007335
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K012854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2016

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: 04/30/2018
• Device Catalogue Number: RSR04
• Device Lot Number: TN11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2016
• Initial Report FDA Received Date: 05/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.035 WIRE