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

Catalog Number	RSR04
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was not available to be 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 production lot number was not provided by the user facility, which prevented a meaningful review of production and complaint records.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 the destination device un-raveled during a case.Follow up communications with the user facility confirmed the following information: the destination device un-raveled upon removal from the patient at the end of a case; it was confirmed that no portion of the product was left in the patient; a 6fr cook ansel was removed and 7fr destination was inserted; the case was performed as planned; the procedure was completed successfully; and there were no patient issue.
Additional Manufacturer Narrative
This report is being submitted as follow up number 1 to provide the retention sample evaluation results.The actual device was not available, therefore the investigation results are based upon the user facility information and retention samples from three recently manufactured lots.No visual anomalies were noted.Dimensional and functional testing confirmed the samples met manufacturing specifications.There is no evidence that this event was related to a device defect or malfunction.The retention samples confirmed the product met manufacturing specifications.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: RENAL GUIDING SHEATH
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 6195050
• Report Number: 1118880-2016-00279
• Device Sequence Number: 10941988
• Product Code: DYB
• UDI-Device Identifier: 00389701006192
• UDI-Public: 00389701006192
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 12/21/2016

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: RSR04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 01/18/2017
• 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: 6FR COOK ANSEL AVINGER ATHERECTOMY DEVICE