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

Catalog Number	50-1060
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	02/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has been received by the manufacturing facility for evaluation.Visual inspection revealed that there was no damage to the sheath.The sheath was then submerged in water and air pressure was applied to conduct a valve leakage test.No leak was observed.Upon partial insertion of the dilator air bubbles were observed indicating a leak.After removal of the dilator, there was no leak observed.The sheath was dissected to remove the cross cut valve.The magnified inspection of the cross cut valve revealed an off-center anomaly on the cross cut valve.A review of the device history record of the product code/lot# combination was conducted with no relevant findings.Two other devices were used in this same event and were also reported to leak, only one actual sample was returned.That sample investigation was conducted within this report.There is no evidence that this event was related to a device defect or malfunction.While the exact cause of the reported event cannot be definitively determined based on the available information, it is likely that the dilator or other device was inserted off-center through the valve causing a flaw off-center of the slit, resulting in the reported leak.The potential for such an event is addressed in the product labeling with statements such as the following: "insert the dilator into the valve center of sheath.Forced dilator insertion missing the valve center may cause valve damage, resulting in blood leakage." 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 during a procedure.Follow up communication with the user facility confirmed the following information: a backflow of blood was reported coming out of the valve from the side port after it is flushed out; blood loss was less than 250 cc; the procedure was completed and the outcome was reported as good; there was no patient injury or medical intervention required, patient is stable; and two other devices were used in this same event and were also reported to leak, see mdr numbers 1118880-2017-00014 and 1118880-2017-00015.

• Brand Name: GLIDESHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 6428042
• Report Number: 1118880-2017-00013
• Device Sequence Number: 19047810
• Product Code: DYB
• UDI-Device Identifier: 00389701011332
• UDI-Public: (01)00389701011332(17)180831(10)UG22
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K142183
• 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
• Report Date (Section B): 03/23/2017

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: 11/30/2018
• Device Catalogue Number: 50-1060
• Device Lot Number: UG22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2017
• Initial Report FDA Received Date: 03/23/2017
• 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: CATHETERS; WIRES
• Patient Age: 61 YR