MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	5833150
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Investigation summary: one 14.5 fr d/l hemostat vas-cath 15cm catheter with surecuff kit was returned for evaluation.The guidewire was returned inside the introducer needle and could not be advanced through the needle.When viewed under magnification, tissue was noted between the needle bevel and the guidewire.The guidewire was removed with resistance noted.After removal, it was noted that the outer coil wire was stretched with the distal ends of the inner core wires exposed.Based on this finding, the investigation is unconfirmed for a guidewire/needle fit issue and confirmed for a frayed guidewire.It is likely that the identified frayed guidewire issue was perceived as a fit issue, as it would prevent the wire from moving normally within the needle.Additionally, per the evaluation results, it was noted that there was tissue noted between the needle bevel and the guidewire, a characteristic typical of retraction of the guidewire against the needle bevel.Therefore, it is possible that damage due to retraction during use contributed to the reported and identified issues.However, the definitive root cause could not be determined based upon the available information.
Event or Problem Description
It was reported the guide wire was stuck in the introduction needle.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: HEMOSTAR DIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8189336
• Report Number: 3006260740-2018-03705
• Device Sequence Number: 19339666
• Product Code: MSD
• UDI-Device Identifier: 00801741013317
• UDI-Public: (01)00801741013317
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

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: 06/30/2019
• Device Model Number: 5833150
• Device Catalogue Number: 5833150
• Device Lot Number: REBU1885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2018
• Initial Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1