MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION GLIDESHEATH; INTRODUCER CATHETER

Catalog Number	15-1060
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	04/21/2016
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.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: the sheath leaked from the valve persistently during the procedure from the time the catheter was inserted until the sheath was removed from the body.Blood loss was less than 250ml.The procedure was completed successfully.The patient was reported as in stable condition.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide a status update on the evaluation.The investigation has yet to be completed.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.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Additional Manufacturer Narrative
This report is being submitted as follow up # 2 to provide the retention sample evaluation results.The actual device was discarded by the facility and is not available for evaluation.Therefore the investigation results are based upon the user facility information and the evaluation of the retention samples from the reported product code/lot# combination as well as two previous lots.A visual examination of the retention samples confirmed there were no visual defects.Functional 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 with no anomalies which would lead to the reported leak.Without the actual complaint sample 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: GLIDESHEATH
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 5667616
• Report Number: 1118880-2016-00172
• Device Sequence Number: 87937
• Product Code: DYB
• UDI-Device Identifier: 00389701009384
• UDI-Public: 00389701009384
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K102008
• 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): 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 Expiration Date: 05/31/2018
• Device Catalogue Number: 15-1060
• Device Lot Number: TP16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/21/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/19/2016
• Supplement Report FDA Received Date: 06/17/2016; 06/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1