MAUDE Adverse Event Report: BARD ACCESS SYSTEMS VAS-CATH NIAGARA KIT 13.5 F X 15 CM [PRE-CURVED SHORT TERM DUAL-LUMEN]; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	5594150
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guide of 2 niagara catheter stay blocked in the needle then deformed "to shrinkage" at the time of removal.This file address the second catheter.On 07/12/2017- evaluation found damaged dilator tips.No damage to guidewire noted.Hm.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 report of damaged dilator tips is confirmed, and the cause is determined to be use-related.The samples returned are two dilators and one guidewire, reportedly from a niagara pc dual lumen 15 cm kit.Visual observation found that the two dilators each had deformation at the tip.The longer (wider and of 21.3 cm functional length) had a distal orifice of an oval/egg shape, and the shorter (thinner and of 14.8 cm functional length) had a distal orifice of a teardrop shape.In both cases, whitened material had been pushed up outward from the circumference.The guidewire was 0.037¿ in diameter, had two sharp bends, at about 1 cm from center of 35-cm mark, opposite the j-tip, and then about 7.5 cm further from the j-tip, as well as various more gradual bends, and manifested use residue.Microscopic observation confirmed whiteness and deformation at the dilator tips.The weld tips of the guidewire were both intact, which was confirmed tactually.Functional testing found that the j-tipped guidewire could pass into and through each of the dilators, with noticeable resistance.The sharpness of the bends were noticeably decreased after this evaluation.No needle(s) was returned for evaluation.The degree of damage to the dilator tips and the wire suggests significant force was applied during use.A relatively sharp angle of insertion of the dilators against the wire is also a possible contributing factor.The complaint event is therefore likely use-related.The wire kinks are near the middle of the wire, and are severe.The locations of the kinks in this nominally 70-cm guidewire (about 1 cm from center of 35-cm mark, opposite the j-tip, and then about 7.5 cm further from the j-tip) suggests they would probably not have been located within the body during the procedure.The distance between kinks is approximately the difference in the lengths of the two dilators, which suggests the possibility that while the position of the distal end of the wire was held constant in the patient, the wire was kinked with the insertion of the first dilator, at the hub, and similarly with the second in turn.The following ifu statement may be helpful: ¿use the dualator* vessel dilator(s) to dilate the subcutaneous tissues.For the niagara* catheter, it is recommended that the 11-13 fr.Dualator*dilator be used first followed by the 12-14 fr.Dualator* dilator, if additional dilation is desired.Dilate 2-3 times with slow, gradual advancements.One size dilator (11-13 fr.) is provided with the niagara* slim-cath* catheter.The larger portion of the dualator* dilator device must enter the vein prior to catheter insertion.¿.
Event or Problem Description
It was reported that the guide of 2 niagara catheter stay blocked in the needle then deformed "to shrinkage" at the time of removal.This file address the second catheter.07/12/2017- evaluation found damaged dilator tips.No damage to guidewire noted.

• Brand Name: VAS-CATH NIAGARA KIT 13.5 F X 15 CM [PRE-CURVED SHORT TERM DUAL-LUMEN]
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6769104
• Report Number: 3006260740-2017-01224
• Device Sequence Number: 16168791
• Product Code: MPB
• UDI-Device Identifier: 00801741045608
• UDI-Public: (01)00801741045608
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K030268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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: 06/28/2018
• Device Model Number: 5594150
• Device Catalogue Number: 5594150
• Device Lot Number: REZF0776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/17/2017
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1