MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 6 FR DL POWERLINE CATHETER, INTERMEDIATE KIT; INTRAVASCULAR CATHETERS

Catalog Number 0700610

Device Problem Malposition of Device (2616)

Patient Problem Infiltration into Tissue (1931)

Event Date 02/13/2017

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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reax0254 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the facility that their was infiltration which required the patient to undergo an additional procedure.

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), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed, and the cause is determined to be use-related.The device returned is one powerline 6 fr dual lumen polyurethane catheter with surecuff.Tactual evaluation found evidence of clamping on both extension legs.Visual observation found residue at and proximal to the cuff.The printing on the bifurcation hub and extension legs was in good condition.Functional testing found both lumens to be patent to infusion and aspiration.When infusing the red lumen, a leak was found at the distal end of the cuff.At one point, during infusion, water came out of the opposite luer.Later, this was not reproduced.It is therefore suspected to be due to expansion of one lumen forcing fluid out of the other.Microscopic evaluation found two horizontal lines extending out distally from the cuff.One of these lines was a hole, and the other did not extend through the wall; both were on the red lumen side of the septum.The break surface of the hole did not appear striated, leading to the conclusion that this damage was not caused by a sharp instrument, but rather a tearing failure mode.The lines parallel to the axis at the cuff, including the hole, as well as the preferential kink noted at that location, are consistent with repeated bending at that site which finally resulted in fracture.The failure is therefore likely use-related.The following statements in the ifu may be helpful: ¿the catheter must be secured in place to minimize the risk of catheter breakage and embolization.¿ avoid accidental device contact with sharp instruments and mechanical damage to the catheter ¿material.Use only smooth edged, atraumatic clamps or forceps.¿ ¿do not use the catheter if there is any evidence of mechanical damage or leaking.Avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen(s).¿ ¿close the skin at the venipuncture site as necessary, taking care not to damage the catheter.¿ ¿suture catheter wings (or use statlock* device) and suture catheter at exit site using removable suture wing.(avoid nicking catheter with suture needle.)¿ ¿secure catheter at exit site with a sterile dressing.Avoid tension on the catheter segment to prevent dislodging the catheter.¿.

• Brand Name: 6 FR DL POWERLINE CATHETER, INTERMEDIATE KIT
• Type of Device: INTRAVASCULAR CATHETERS
• 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: 6392972
• MDR Text Key: 69849776
• Report Number: 3006260740-2017-00214
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741036590
• UDI-Public: (01)00801741036590(17)210331(10)REAX0254
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 0700610
• Device Lot Number: REAX0254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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