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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	07/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has been returned to the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.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 found four similar reports with the involved product code/lot# combination.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 they had a sheath that was leaking at the valve.The following information was provided by the user facility: blood loss was approximately 10cc's.Additional information was received on july 31,2017.The patient was stable.The procedure outcome was successful.A 5fr cath impulse was used with the reported product.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the completed investigation results.There is no evidence that this event was related to a device defect or malfunction.With no device return 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.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the evaluation.A device return date was reported in the initial report.The actual device was not returned for evaluation.Therefore, the investigation was based on the user facility information and the device history records.No evaluation could be conducted due to the device not being returned.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.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: 6810797
• Report Number: 1118880-2017-00059
• Device Sequence Number: 16393464
• Product Code: DYB
• UDI-Device Identifier: 00389701011042
• UDI-Public: 00389701011042
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 08/22/2017

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: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 40-1060
• Device Lot Number: VD29
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/03/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 08/07/2017; 09/15/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 08/31/2017; 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1