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

Catalog Number	5393190
Medical Device Problem Codes	Collapse (1099); Restricted Flow rate (1248); Suction Problem (2170); Deformation Due to Compressive Stress (2889); Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
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, 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 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.
Event or Problem Description
It was reported that sometimes post dialysis catheter placement, the catheter was allegedly kinking where it is clamped.It was further reported that the catheter tubing seems to suction while patient is getting dialysis.There was no reported patient injury.
Event or Problem Description
It was reported that one year and thirty days post a dialysis catheter placement, the catheter was allegedly kinking where it is clamped.It was further reported that there was reduced blood flow.Additionally, the stem of the tubing coming out of the chest wall at the exit site started to collapse during the treatment.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as this is the first complaint reported for this product and lot.Investigation summary: the physical device was not returned for evaluation.However, one electronic photo was provided for review.The photo shows a clinician holding an implanted catheter in which the arterial lumen is noted to be compressed / deformed.Therefore, the investigation is confirmed for the reported catheter kink issue.However, the investigation is inconclusive for the reported restricted blood flow, collapse and expulsion issues as no objective evidence was obtained from the provided photo.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.H10: d4 (expiration date, unique identifier (udi) #), d6a, g3, h6 (device, method).H11: b3, b5, d4 (medical device catalogue #, medical device lot #), g4, h6 (result, conclusion).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
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: although the physical device was not returned for evaluation, one photo was provided for review.The photo shows a clinician holding an implanted catheter in which the arterial lumen is noted to be compressed/ deformed.Therefore, the investigation is confirmed for the reported catheter kink issue.However, the investigation is inconclusive for the reported restricted blood flow and collapse issues as no objective evidence was obtained from the provided photo.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.D4 (unique identifier (udi) #), g3, h6 (device, component) 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 one year and thirty days post a dialysis catheter placement, the catheter was allegedly kinking where it is clamped.It was further reported that there was reduced blood flow.Additionally, the stem of the tubing coming out of the chest wall at the exit site started to collapse during the treatment.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: 21466896
• Report Number: 3006260740-2025-00999
• Device Sequence Number: 8714090
• Product Code: MSD
• UDI-Device Identifier: 00801741012174
• UDI-Public: (01)00801741012174(11)230223(17)241130(10)REHN2471
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2026

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: 11/30/2024
• Device Catalogue Number: 5393190
• Device Lot Number: REHN2471
• 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: 01/31/2025
• Supplement Date Received by Manufacturer: 05/14/2025; 05/18/2026
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 05/16/2025; 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2023
• 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