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

Model Number 5833690

Device Problems Bent (1059); Material Frayed (1262)

Patient Problem No Information (3190)

Event Date 10/12/2017

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reaz0917 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the physician that the needle was found to be bent during the pre-test.A new device was opened to complete the procedure.On 02/07/2018, evaluation found the guidewire was frayed and lodged within the needle.

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 damaged guidewire was confirmed and the cause was determined to be use related.The product returned for evaluation was a 0.038" x 70cm guidewire with an 18ga introducer needle.The investigation findings are consistent with damage caused by retraction of the guidewire against the bevel of the introducer needle.The needle was not observed to be bent.The returned product sample was evaluated and the guidewire was confirmed to be broken with the coil wire being unraveled.It appeared that the inner core wire had broken which allowed the outer coil wire surrounding it to unravel.Microscopic examination of the fracture sites revealed the following: narrowing of the wire cross-section near the fracture site, which is a characteristic feature of a strong pull on the wire.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.A region of tightly coiled wire was immediately adjacent to a region of loosely coiled wire which was indicative of the contact point with the needle.Biological material was also seen on the wire which may 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.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 reaz0917 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the physician that the needle was found to be bent during the pre-test.A new device was opened to complete the procedure.02/07/2018-evaluation found the guidewire was frayed and lodged within the needle.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (19CM)
• Type of Device: BLOOD ACCESS 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 7304074
• MDR Text Key: 101658811
• Report Number: 3006260740-2018-00302
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013386
• UDI-Public: (01)00801741013386
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• 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: REAZ0917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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