MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA DIALYSIS CATHETER KIT 13.5F X 20CM (PRE-CURVED) (SHORT-TERM) (D/L); CATHETER, HEMODIALYSIS, NON-IMPLANTED

Catalog Number 5594200

Device Problems Material Frayed (1262); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2018

Event Type  malfunction  

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, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a stuck guidewire was confirmed and appears to be use related.The alleged and returned sample is an opened niagara short-term dialysis catheter kit.Kit contents include: niagara catheter with stylet, x2 dilators, 70cm guidewire, introducer needle, suture wing, x2 injection caps, and literature.The guidewire was returned within the guidewire hoop with the distal end going through the introducer needle with the pink hub.The "j" tip segment of the guidewire was observed to be extending past the distal end of the introducer needle.Use residue was observed at the distal end of the needle.An attempt to advance the guidewire was unsuccessful and was likely caused by the dried use residue between the needle and guidewire.Microscopic observation of the needle bevel revealed material deformation which was likely cause due to retraction of the guidewire.An attempt to retract the guidewire revealed the guidewire to extend back with slight resistance and felt elastic.The j tip curled when the guidewire was pulled.This is indicative that the core wire was broken.A gripping tool was used to attempted to remove the guidewire from the distal end and the core wire stuck out when the coils were expanded.The guidewire was removed from the distal end of the needle.The proximal end of the guidewire was passed through the introducer needle without issue.The outer diameter of the guidewire was measured and found to be within specification.Since the guidewire was found to be frayed and material damage was observed on the needle bevel, it is likely that the complaint of the guidewire getting stuck in the needle is use related.The ifu states ¿do not pull back guidewire over needle bevel as this may sever the end of the guidewire.The introducer needle must be removed first.Also, if unusual resistance is met during manipulation of the guidewire, discontinue the procedure and determine the cause of resistance before proceeding.Withdraw needle and guidewire if cause of resistance cannot be determined.¿ a lot history review (lhr) of recp1735 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported that when the doctor tries to pass the guide through the needle, the guide is stuck at 2 or 3 cm, the guide was removed with the needle as a whole.On (b)(6) 2018-returned guidewire is frayed.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 20CM (PRE-CURVED) (SHORT-TERM) (D/L)
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7936800
• MDR Text Key: 122808429
• Report Number: 3006260740-2018-02732
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045615
• UDI-Public: (01)00801741045615
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K030268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2012
• Device Catalogue Number: 5594200
• Device Lot Number: RECP1735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1