MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (19CM); CATHETER, HEMODIALYSIS, IMPLANTED

Model Number 5833690

Device Problem Sticking (1597)

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

Event Date 07/14/2017

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 following were reviewed as part of this investigation: patient severity, frequency 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 a stuck guidewire was confirmed and the cause was determined to be use related.The product returned for evaluation was an 18ga x 2.75in introducer needle and a 0.038" 70cm guidewire.The investigation findings are consistent with damage caused by retraction of the guidewire against the bevel of the introducer needle.The returned product sample was evaluated and the guidewire was confirmed to be firmly lodged within the introducer needle and the core wire was broken.Microscopic examination of the needle/tip wire region revealed the damage to the inside edge of the introducer needle which can occur if the guidewire is forcefully retracted against the needle, damaging the shape of the sharpened bevel.Additionally, biological material was seen between the wire and needle which appeared to have contributed to the observed guidewire fracture as retraction of the wire together with the biological material could have caused the pieces to become stuck.The wire was then forced through the needle and dark red, hardened, fibrous, residue was observed to thickly coat the wire which confirmed the cause of the event.Normal movement of the guidewire is away from the sharpened bevel and will not damage the wire.If the guidewire direction is reversed, the guidewire is then pulled against the sharpened edge of the needle bevel and can cause shearing damage of the wire and/or cause the wire to become stuck within the needle.The product instruction for use (ifu) contains the following information which may be relevant to this type of event, "do not pull back standard guidewire over needle bevel as this could sever the end of the guidewire.The introducer needle must be removed first." an examination of the wire structure revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) of rebp1080 showed one other similar product complaints from this lot number.

Event Description

It was reported by the facility that the guidewire was "stuck with the needle".No reported patient injury.On (b)(6) 2018 - the returned guidewire was frayed.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (19CM)
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• 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: 7289765
• MDR Text Key: 100914080
• Report Number: 3006260740-2018-00256
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013386
• UDI-Public: (01)00801741013386
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5833690
• Device Catalogue Number: 5833690
• Device Lot Number: REBP1080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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