MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT; LONG TERM HEMODIALYSIS CATHETER

Catalog Number	5835150
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire was confirmed, and the cause appears to be related to use of the device.The 0.038¿ guidewire from a hemostar dialysis kit was returned for investigation.The other components from the kit, except the introducer needle, were returned unused with the damaged guidewire.The coil wire was stretched and elongated over the distal end of the core wire.The distal tip of the core wire was visible through the elongated coil wire.The distal 1.5cm section of the coil wire was still tightly coiled.No parts of the guidewire were missing.The coil wire was stretched just proximal to the distal weld tip, which revealed that the core wire broke at the weld.The break in the core wire allowed the coil wire to stretch over the core wire.A tactual investigation revealed that the coil and core wires were intact at the proximal weld tip.The distal end of the coil wire could be stretched over the distal tip of the core wire.The distal end of the guidewire, which was still intact, passed through an 18g needle without difficulty.The outside diameter (od) of the guidewire was within specification.The damage observed on the returned sample is consistent with a break of the core wires under tensile stress.This can occur if the guidewire becomes lodged in the needle during use.One of the cautions in the ifu states, ¿do not pull back standard guidewire over needle bevel as this could sever the end of the guidewire.The introducer needle must be removed first.¿ a lot history review (lhr) of reas0706 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was originally reported by the facility that the guidewire was "faulty".Bard sales representative clarified that when he inspected the wire, he noticed it was uncoiled.The facility reported to him that the procedure was completed with a new guidewire and this occurred during the early stage of insertion with the needle and guidewire.There was no reported patient injury.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT
• Common Device Name: LONG TERM HEMODIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6183533
• Report Number: 3006260740-2016-00686
• Device Sequence Number: 10864763
• Product Code: MSD
• UDI-Device Identifier: 00801741013485
• UDI-Public: (01)00801741013485(17)180228(10)REAS0706
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/24/2016

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: 02/28/2018
• Device Catalogue Number: 5835150
• Device Lot Number: REAS0706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2016
• Initial Report FDA Received Date: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1