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

Model Number	5594150
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2017
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reaz0008 showed no other similar product complaint(s) from this lot number.Device not returned, at this time.
Event or Problem Description
It was reported that the guidewire was threaded into the vein with ease, then the catheter was threaded in without any resistance.When attempting to remove the guidewire the physician met resistance and the guidewire appeared to be only stretching.The physician removed the entire catheter to get the guidewire out.Procedure was started again and the physician experienced the same issue.The procedure was stopped.No injury to the patient was reported.
Additional Manufacturer Narrative
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 is confirmed and was determined to be use related.One 15 cm niagara catheter, one plastic stylet, and one j-tip stainless steel guidewire were returned for evaluation.An initial visual observation showed the guidewire and stylet were returned inserted into the blue lumen of the catheter.Blood residue was observed on all of the samples.The guidewire was observed to be bent in multiple locations.The core wires of the guidewire were observed to be broken during tactile evaluation.The guidewire was observed to be stuck in the position it was returned in.The stylet was able to be removed without much resistance.The guidewire could not be pulled out of the stylet but was able to be removed by pushing it through.Blood residue was observed throughout the length of the guidewire once it was removed from the stylet.The guidewire was reinserted into the stylet and very little resistance was felt until the sections of the guidewire that were bent were inserted into the stylet.The stylet was observed to be bent and lighter in color where one of the bends in the guidewire was located within the stylet.A microscopic observation revealed both weld tips were intact and undamaged; however the coil wire of the guidewire was slightly unraveled near the weld tip of the straight end.The core wires were observed to be broken near the weld tip at the straight end of the guidewire.The fracture sites of both core wires were observed to be tapered and granular in texture, which is typical of tensile breaks.Due to the location and nature of the bends and damage observed on the guidewire and stylet the cause of this complaint was determined to be use related.The product ifu states: ¿flush each lumen with heparinized saline prior to insertion and clamp the arterial (red) lumen.Do not clamp the venous (blue) lumen until the venous insertion stylet and guidewire are removed.¿.
Event or Problem Description
It was reported that the guidewire was threaded into the vein with ease, then the catheter was threaded in without any resistance.When attempting to remove the guidewire the physician met resistance and the guidewire appeared to be only stretching.The physician removed the entire catheter to get the guidewire out.Procedure was started again and the physician experienced the same issue.The procedure was stopped.No injury to the patient was reported.

• Brand Name: VAS-CATH NIAGARA KIT 13.5 F X 15 CM [PRE-CURVED SHORT TERM DUAL-LUMEN]
• Common Device Name: NON-IMPLANTED BLOOD ACCESS DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6815165
• Report Number: 3006260740-2017-01397
• Device Sequence Number: 60439
• Product Code: MPB
• UDI-Device Identifier: 00801741045608
• UDI-Public: (01)00801741045608
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• PMA/510(K) Number: K030268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2017

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 Model Number: 5594150
• Device Catalogue Number: 5594150
• Device Lot Number: REAZ0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 86