MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 19 CM HEMOSTAR ALPHACURVE STANDARD KIT; LONG TERM HEMODIALYSIS CATHETER

Catalog Number 5835150

Device Problem Bent (1059)

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

Event Date 12/06/2016

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 damaged guidewire was confirmed, and the cause appears to be related to use of the device.One 18g introducer needle and guidewire were returned for investigation with an unused hemostar catheter and other unused kit accessories.The distal tip of the guidewire was received lodged inside the needle shaft.The distal j-bend of the guidewire was not visible within the distal opening of the introducer needle.Blood residue was observed on the guidewire.A tactual investigation revealed that the coil wire could be stretched over the core wires.The distal end of the guidewire was forcefully removed from the needle.A microscopic examination of the guidewire revealed deformation in the weld tip.Deformation was also observed along the inner beveled edge of the needle, which indicates that the guidewire was retracted within the needle.The coil wire was stretched just proximal to the distal weld tip, which revealed that the core wire broke at the weld.After flushing residue from the needle, 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 guidewire over needle bevel as this could 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 reaq1006 showed one other similar product complaint(s) from this lot number.Both complaints for this lot number (reaq1006) have been reported from the same (b)(4) facility.

Event Description

It was reported that a guidewire was opened and bent during insertion.A new guidewire from a different line was used successfully.There was no reported patient injury.

• Brand Name: 19 CM HEMOSTAR ALPHACURVE STANDARD KIT
• Type of Device: LONG TERM HEMODIALYSIS CATHETER
• 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6354827
• MDR Text Key: 68470350
• Report Number: 3006260740-2017-00145
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 0081741013485
• UDI-Public: (01)0081741013485(17)180128(10)REAQ1006
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Catalogue Number: 5835150
• Device Lot Number: REAQ1006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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