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

Catalog Number	5396240
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Stretched (1601); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one j-tip guidewire loaded into an introducer needle in a guidewire hoop was received for evaluation.Visual, dimensional observation, microscopic and functional evaluations were performed on the returned device.The distal portion of the gw proximal to the introducer needle appeared to have a bend and stretching was observed.An attempt to advance the guidewire could not be performed due to the stretching condition throughout.The round core wire was noted to within the uncoiled/stretch portion of the guidewire.The termination appeared to be a welded round ball.The flat core wire was noted to within the uncoiled/stretch portion of the guidewire.The termination of the flat core wire appeared to be granular.The distal tip of the guidewire was inadvertently stretch to observed for a termination of the flat core wire.Two terminations were found on the distal tip of the guidewire.The investigation is confirmed for the reported failure to advance and identified fracture, material separation, deformation due to compressive stress and stretched issue.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.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.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
On (b)(6) 2025, a patient underwent a dialysis catheter placement procedure using the glidepath hemodialysis catheter.During the procedure, the guidewire could not pass through the introducer needle.The procedure was completed using another device.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: 24514133
• Report Number: 3006260740-2026-01374
• Device Sequence Number: 18250368
• Product Code: MSD
• UDI-Device Identifier: 00801741012259
• UDI-Public: (01)00801741012259(11)250523(17)270228(10)REKR2141
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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: 5396240
• Device Lot Number: REKR2141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2025
• 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