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

Catalog Number	5393310
Medical Device Problem Codes	Stretched (1601); Expulsion (2933); Material Protrusion/Extrusion (2979); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Skin Erosion (2075); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent a dialysis catheter placement procedure using a glidepath hemodialysis catheter.Post the procedure on (b)(6) 2026, it was noted that the catheter had extruded.Reportedly, the catheter was removed.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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.
Additional Manufacturer Narrative
H11: additional information was received, and it was stated cuff was exposed and extruded and hence that the file was reassessed for reportability and determined to be reportable as serious injury.As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow up report will be submitted as applicable.B1, b2, b5, d4 (unique identifier (udi) #), g3, h1, h6 (patient, device, method, result, conclusion).Section a through f :the information provided 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 dialysis catheter placement procedure using glidepath hemodialysis catheter.Post the procedure, it was noted that the cvc cuff had extruded and was exposed.Reportedly, the catheter was removed.The procedure was completed using another device.The current status of the patient was unknown.
Event or Problem Description
On (b)(6) 2026, a patient underwent a dialysis catheter placement procedure using glidepath hemodialysis catheter.Post procedure, it was noted that the cvc cuff had extruded and was exposed.Reportedly, the catheter was removed.The procedure was completed using another device.There was no patient reported injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.The investigation is inconclusive for the reported loosening of implant not related to bone ingrowth and expulsion issues for both the devices as no objective evidence was provided for review.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.G3, h6 (component, method).Section a through f: the information provided 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 dialysis catheter placement procedure using glidepath hemodialysis catheter.Post procedure, it was noted that the cvc cuff had extruded and was exposed.Reportedly, the catheter was removed.The procedure was completed using another device.There was no patient reported injury.
Additional Manufacturer Narrative
H11: upon review, the event was initially misclassified as a serious injury due to inadvertent interpretation of the catheter involved and the term expulsion as skin erosion.Further assessment confirmed that the reported catheter involved was a glidepath dialysis catheter, and the reported issue was catheter cuff extrusion/exposure.There was no reported patient injury.Therefore, the file was reassessed for reportability and determined to be a malfunction.As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow up report will be submitted as applicable.B1, b5, g3, h1, h6 (patient).Section a through f: the information provided 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 24468017
• Report Number: 3006260740-2026-01244
• Device Sequence Number: 16029328
• Product Code: MSD
• UDI-Device Identifier: 00801741012204
• UDI-Public: (01)00801741012204
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5393310
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 02/19/2026; 03/28/2026; 04/10/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/18/2026; 03/31/2026; 04/16/2026
• 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 Sex: Unknown