MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATH LONG-TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET STANDARD KIT; BLOOD ACCESS DEVICE AND ACCESSORIES

Catalog Number 5393230

Device Problems Bent (1059); Stretched (1601); Unraveled Material (1664)

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

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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of complications with the guidewire is confirmed, and the cause is determined to be use-related.The product returned is a broken 0.038¿ guidewire in its hoop with advancing mechanism with a length not exactly determinable due to its condition.In this case, ¿distal¿ refers to nearer the j-tip and ¿proximal¿ means nearer to the straight end.Visual evaluation showed that the guidewire manifested a large amount of residue on its surface, and some residue was found inside the hoop.Examination of the depth markings showed that the wire was evidently approximately 69 cm long.The shorter core wire was broken at the distal end, with a large amount of the coiled wire extending distally, with the region just proximal to the point at which the core wire emerged from the coil wire somewhat stretched.Tactual evaluation showed that the coil wire distal to the broken core wire was much more floppy than the remaining wire.A kink was noted at about 3.4 cm from the j-tip.The coil wire was completely broken at the distal end of the distal 30-cm depth mark.According to preliminary evaluation, this break occurred during decontamination.Microscopic examination showed that both core wires were broken at their respective distal ends.The distal end of the shorter wire retained a ball of metal at the tip, apparently the internal weld tip.The distal end of the longer core wire showed signs of necking both at on the wire and the broken weld tip still attached to the coil wire.The distal end of the coil wire had to be stretched out in order to make this determination.This necking is indicative of a tensile event, consistent with retraction against resistance.Retraction against the needle is a known cause of guidewire breakage, although neither this nor any other needle damage or defects possibly indicative of and/or contributing to this event can be confirmed as no needle was returned.Accumulation of tissue within the needle when retracting a guidewire while in the needle may also result in increased resistance to movement; however, retraction of the guidewire against the needle is contrary to ifu instructions.In any event, it is evident that the guidewire was retracted against resistance, causing it to break.This complaint is therefore confirmed, and the cause is determined to be use-related.The ifu states that if the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.The guidewire should not be pulled back against the needle.A lot history review (lhr) of rean0787 showed no other similar product complaint(s) from this lot number.

Event Description

On 06/27/16 - per sales representative, facility contact reported that when placing a glidepath hemodialysis catheter the needle would go in but would not come out.The health professional opened another catheter to finish the case.On 07/29/2016 - during decontamination on (b)(6) 2016, the wire was found to have blood residue and was bent, unraveled, and stretched with the core wire broken.On 08/11/16 - facility confirmed that the "guidewire would not go in".They originally reported that the needle would not advance.

• Brand Name: GLIDEPATH LONG-TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET STANDARD KIT
• Type of Device: BLOOD ACCESS DEVICE AND ACCESSORIES
• 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: maren treft ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225964
• MDR Report Key: 5886251
• MDR Text Key: 53391330
• Report Number: 3006260740-2016-00435
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 0080174102181
• UDI-Public: (01)0080174102181(17)180128(10)REAN0787
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• 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: 5393230
• Device Lot Number: REAN0787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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