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	07/20/2017
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.(b)(4).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 find two other reports with the involved product code/lot# combination.The same user facility reported a similar events for another device with the same product code/lot number combination, see mdr 1118880-2017-00054, 1118880-2017-00055, 1118880-2017-00057.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.The following information was provided by the user facility: customer states that the valve is leaking (moderate-severe) more than usual when there is nothing in the valve (wire, catheter, etc.).Used with.035 3mm j wire.Blood loss was reported to be less than 250cc.The procedure outcome was successful.It was reported that there was no patient issues.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to correct the mfr report no.That was reported in follow up report.

• Brand Name: GLIDESHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 6785785
• Report Number: 1118880-2017-00056
• Device Sequence Number: 16607686
• 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): 08/10/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 09/20/2017; 09/26/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 09/20/2017; 10/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1