MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GlidePath; Dialysis Catheter

Catalog Number	5393230
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.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) 2026, a patient underwent a catheter placement procedure using the glidepath hemodialysis catheter.During the procedure, the stiffener broke off inside the patient over the guidewire.The physician retrieved the broken piece using a snare.The current status of the patient is unknown.
Event or Problem Description
On (b)(6), 2026, a 66-year-old patient underwent a catheter placement procedure through right internal jugular vein using the glidepath hemodialysis catheter.During the procedure, the stiffener broke off inside the patient over the guidewire.It was further reported that, during insertion of the new glidepath catheter and stiffener into the venous circulation, the device would not advance completely into the patient.Due to extreme resistance encountered during advancement, further advancement was stopped.The physician subsequently retrieved the broken stiffener fragment using a snare.The catheter and stiffener had only been advanced to the cavoatrial junction; therefore, it was presumed that the section of the wire distal to the atrium still contained the remaining stiffener.The patient is stable and no reported patient injury.
Additional Manufacturer Narrative
H11: based on the additional follow-up information, it was determined that the allegation involved the pieces of the stiffener were so thinned out from deformation of the plastic during retraction, the stiffener could not be identified as separate from the guidewire on imaging.The catheter and stiffener had only been advanced to the cavoatrial junction, so it was presumed that the portion of the wire below the atrium did contain remaining stiffener.As the allegation of a foreign body remaining in the patient could not be verified, the foreign body code was removed.The file was reassessed for reportability and determined to be reportable as malfunction.Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.The investigation is inconclusive for the reported stiffener farcture, material separation, physical resistance/sticking and failure to advance issues as no objective evidence was provided for review.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H.4.Device manufacture date: unknown b1, b5, g3, h1, h6 (patient, device, method, result, conclusion) 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.

• 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 25404066
• Report Number: 3006260740-2026-03921
• Device Sequence Number: 10302433
• Product Code: MSD
• UDI-Device Identifier: 00801741012181
• UDI-Public: (01)00801741012181(17)270731(10)REKW1214
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: 5393230
• Device Lot Number: REKW1214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 09/25/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Unknown
• Patient Weight: 196 LB