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

Catalog Number	40-1060
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	12/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi number for this product code/lot number combination is not required.The di portion is provided.The actual device has not been 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.For this reason code was used in the conclusions.A review of the device history record of the product code/lot# combination confirmed there were no production related problems.The user facility reported two devices from the same product code/lot number combination, also see mdr 1118880-2016-00277.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 valve leakage on the involved device.Follow up communication with the user facility confirmed the following information: it was reported that in two separate events, two of the same sheaths were used and they did not seal at the valve; this caused blood to leak from the device; blood loss was less than 250 ml; the procedure was completed; and the patient was reported as doing fine.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information on the event description & to provide the status of this report.The actual device has not been received 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.
Event or Problem Description
Additional information was reported by the user facility: the two reported devices were used on two separate patients.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide updated information on the actual sample as well as provide the retention samples investigation results.The actual device was not returned to the manufacturing facility for evaluation.Therefore the investigation is based upon the user facility information and the evaluation of the retention samples from the involved product code/lot number as well as the surrounding lots.Visual examination of the retention samples confirmed there were no defects.Leakage testing confirmed the products met manufacturing specification.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 issue 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: 6195021
• Report Number: 1118880-2016-00278
• Device Sequence Number: 19186910
• Product Code: DYB
• UDI-Device Identifier: 00389701011042
• UDI-Public: 00389701011042
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K152173
• 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): 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 Expiration Date: 11/30/2018
• Device Catalogue Number: 40-1060
• Device Lot Number: UG22
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/02/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 01/17/2017; 02/14/2017
• 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: DIAGNOSTIC CATHETERS