MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT 13F BASIC KIT (TRIPLE-; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a kinked guidewire was confirmed and appears to be related to the use of the device.Two guidewires and one 14 fr dilator were returned for investigation.One of the two guidewire was returned frayed and the other was intact.Both guidewire were observed to contain multiple bends and kinks.The frayed guidewire was observed to have kinks approximately 30 cm from the distal end and a slight bend 5 cm from the distal end.The distal weld tip was present.The intact guidewire was also observed to have kinks approximately 40 cm from the distal end.Microscopic observation of the frayed guidewire revealed the core wire to have an uneven break.The outer diameters of the guidewires were measured and were found to be within specification.One section of the dilator orifice was flared outwards and showed material whitening.The dilator was likely damaged during forceful removal of a kinked guidewire.Based on the condition of the returned samples, possible contributing factors include advancement or retraction of the guidewire against resistance and damage to guidewire during use.A lot history review (lhr) of redr1642 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redr1642) have been reported from the same facility in (b)(6).
Event or Problem Description
The following was reported: the customer hands over the guide wire of a power trialysis catheter to the sales rep.This was removed after the catheter was successfully placed in the femoral artery.The guide wire kinked several times, and the wire pulled apart.The patient was not harmed.The users also reported that the enclosed dilator shows small edges at the tip.This has been noticed several times.No harm to the patient here either.4/27/2020-two samples were returned.This report addresses the second sample.

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT 13F BASIC KIT (TRIPLE-
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10018313
• Report Number: 3006260740-2020-01624
• Device Sequence Number: 3117238
• Product Code: NIE
• UDI-Device Identifier: 00801741041914
• UDI-Public: (01)00801741041914
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2020

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: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 5608240
• Device Lot Number: REDR1642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1