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 Fluid/Blood Leak (1250); Hole In Material (1293)

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

Event Date 12/11/2017

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 rebs2167 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the sales rep that the facility reported that there was a hole in both dialysis "accesses" and they were leaking.The catheter was replaced.The sales rep reported the vessel was not pre-dilated, the right chest was the access site, the delivery system was flushed prior to use, the anatomy of the tracking vessel was not tortuous or calcified, the user did not have difficulties in advancing the delivery system to the target lesion and there were no difficulties retracting the delivery system from the patient.The sales rep reported that there was no patient harm, however the patient would require another procedure in three days.It was reported that another manufacturers guidewire was used and no introducer sheath was used.

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 leak in the catheter was confirmed, and the damage appeared to be associated with use.One 19cm hemostar catheter was returned for investigation.The catheter exhibited evidence of use.Residue was found throughout the fibers of the cuff.Debris was observed on the extension legs and on the clamps.Both extension legs exhibited deformation just distal to the white sleeve.The extension leg material blistered outward.A breach was observed in the deformed region of the extension leg with the red connector.A microscopic examination revealed thinning of the extension leg material in the region of deformation.The damage is consistent with deformation from overpressurization.A functional test confirmed a leak from the breach in the extension leg with the red connector.No other leaks were observed.The wall thickness of each extension leg was within specification.The ifu states, ¿to avoid damage to vessels and viscus, infusion pressures should not exceed 25 psi (172 kpa).The use of a 10ml or larger syringe is recommended because smaller syringes generate more pressure than larger syringes.Note: a three pound (13.3 newton) force on the plunger of a 3ml syringe generates pressure in excess of 30 psi (206 kpa) whereas the same three pound (13.3 newton) force on the plunger of a 10ml syringe generates less than 15 psi (103 kpa) of pressure.¿ the ifu also states, ¿excessive force should not be used to flush an obstructed lumen.¿ no further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rebs2167 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the sales rep that the facility reported that there was a hole in both dialysis "accesses" and they were leaking.The catheter was replaced.The sales rep reported the vessel was not pre-dilated, the right chest was the access site, the delivery system was flushed prior to use, the anatomy of the tracking vessel was not tortuous or calcified, the user did not have difficulties in advancing the delivery system to the target lesion and there were no difficulties retracting the delivery system from the patient.The sales rep reported that there was no patient harm, however the patient would require another procedure in three days.It was reported that another manufacturers guidewire was used and no introducer sheath was used.

• 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: 7201075
• MDR Text Key: 97778809
• Report Number: 3006260740-2018-00015
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013386
• UDI-Public: (01)00801741013386
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 5833690
• Device Catalogue Number: 5833690
• Device Lot Number: REBS2167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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
• Patient Age: 61 YR
• Patient Weight: 91