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

Catalog Number	15-1050
Medical Device Problem Codes	Fracture (1260); Uncoiled (1659)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The wire was returned to the manufacturer for evaluation.Visual inspection revealed the over-coil was coming off the core wire towards the distal end of the wire.An evaluation of the retention sample from the reported product code/lot# combination and two additional retention samples was conducted.There were no visual anomalies noted.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.While the exact cause of the reported event cannot be definitively determined based on the available information, the cause of the wire damage and the wire breaking is likely due to the wire being pulled back through the metal needle cannula.The device labeling does address the potential for such an event in the instructions-for- use (ifu): "when using metal needle cannula do not withdraw the guidewire back into the cannula, as shearing of the guidewire may result." all available information has been forwarded to the manufacturing facility for appropriate tracking, trending and follow up.
Event or Problem Description
The user facility reported uncoiling of the wire during a procedure.Follow up communication with the user facility confirmed the following information: the case used a 5fr glidesheath; after the sheath was placed in the patient the dilator was removed and then the wire; upon pulling the wire out, it was noted that the tip of the wire was shredding and uncoiling; under fluro there was nothing observed to be broken off in the patient; the procedure outcome was good; and there was no patient injury or medical intervention required.

• Brand Name: GLIDESHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 6057707
• Report Number: 1118880-2016-00253
• Device Sequence Number: 1838413
• Product Code: DYB
• UDI-Device Identifier: 00389701009926
• UDI-Public: (01)00389701009926(17)180630(10)UA13
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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
• Report Date (Section B): 10/26/2016

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: 06/30/2018
• Device Catalogue Number: 15-1050
• Device Lot Number: UA13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2016
• Initial Report FDA Received Date: 10/26/2016
• 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: SHEATH