MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GLIDEPATH; DIALYSIS CATHETER

Catalog Number	5397270
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Restricted Flow rate (1248); Nonstandard Device (1420); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that three months and twenty-seven days post a dialysis catheter placement procedure, the catheter marks began to appear in the tubes where the clamps had been closed.This caused suction during dialysis.Reportedly the flow was compromised, and cuff was moved during dialysis.The problem continued to increase gradually and need to be replaced soon.A different type of material should be used for the hose piece with clamps.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H11: section a through f - the information provided by bd 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 bd.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the sample was not returned for evaluation.One electronic photo was provided for review.The photo shows a dialysis glidepath catheter which is implanted in the patient, a pinch can be noted in the clamping site on both the extension legs.Therefore, the investigation is confirmed for the reported deformation due to compressive stress issue.However, restricted flow and cuff movement issues are inconclusive as there was no sufficient information to confirm the issue.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f: the information provide by bd represents all 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 bd.
Event or Problem Description
It was reported that three months and twenty-seven days post a dialysis catheter placement, the catheter marks began to appear in the tubes where the clamps had been closed.It was further reported that this allegedly caused suction during dialysis.Reportedly, the flow was compromised and the cuff was moved during dialysis.Furthermore, the problem continued to increase gradually and need to be replaced soon.Evidently, a different type of material should be used for the hose piece with clamps.There was no reported patient injury.

• Brand Name: GLIDEPATH
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21053375
• Report Number: 3006260740-2024-08004
• Device Sequence Number: 12800267
• Product Code: MSD
• UDI-Device Identifier: 00801741012310
• UDI-Public: (01)00801741012310
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 5397270
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown