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

Catalog Number	5303100
Medical Device Problem Codes	Restricted Flow rate (1248); Fracture (1260); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that three months and nineteen days post dialysis catheter placement procedure, the outer part of the lines allegedly tends to remain crushed at the clamps, affecting the lumen of the catheter.It was further reported that it did not break completely, however it looks like it cannot get back to its original round shape.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned for evaluation.One electronic photo was provided for review.The photo shows an implanted catheter which was held by the physician at the clamp site and the extension leg was noted to be deformed/compressed.Therefore, the investigation is confirmed for the reported material deformation due to compressive stress issue.However, the reported fracture issue is inconclusive as the photo evidence provided is not sufficient to confirm fracture issue.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.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.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H11: 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
It was reported that three months and twenty-six days post a dialysis catheter placement, the outer part of the line was allegedly tended to remain crushed at the clamp, affecting the lumen of the catheter and the pressure.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: although the sample was not returned for evaluation, one electronic photo was provided for review.The photo shows an implanted catheter which was held by the physician at the clamp site and the extension leg was noted to be deformed/compressed.Therefore, the investigation is confirmed for the reported material deformation due to compressive stress and restricted flow rate issues.However, the reported fracture issue is inconclusive as the photo evidence provided is not sufficient to confirm fracture issue.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.B5, g3, h6 (device, component, result) 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) 2024, a patient underwent a dialysis catheter placement procedure using a glidepath catheter.Post the procedure on (b)(6) 2024, the outer part of the lines allegedly tends to remain crushed at the clamps, affecting the lumen of the catheter.It was further reported that it did not break completely.However, it looks like it cannot get back to its original round shape.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: 20732757
• Report Number: 3006260740-2024-06795
• Device Sequence Number: 8395645
• Product Code: MSD
• UDI-Device Identifier: 00801741187285
• UDI-Public: (01)00801741187285(11)231028(17)240930(10)REHU3238
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K200627
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2026

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 Expiration Date: 09/30/2024
• Device Catalogue Number: 5303100
• Device Lot Number: REHU3238
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 01/21/2025; 02/03/2026
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 01/24/2025; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2023
• 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