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

Catalog Number	5393190
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a dialysis catheter placement procedure via the right internal jugular vein approach, the guidewire was allegedly difficult to insert into the dilator.The procedure was completed by using another device.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: one 8fr dilator with a loaded j-tip guidewire were received in two segments.Visual, microscopic, functional and dimensional evaluations were performed.The distal end of the proximal segment of the guidewire was noted to have a complete break and uncoiling was noted at the break end.The distal guidewire segment was received within the 8fr dilator, and the dilator was noted to be bent.The distal tip of the j-tip guidewire appeared to be protruding from the distal tip of the 8fr dilator and the core wires were not visible.The proximal end of the distal guidewire segment was noted to be slightly uncoiled.An attempt to offload the j-tip guidewire from the 8fr dilator was performed and was successful.Therefore, the investigation is confirmed for the identified fracture, stretched and material separation issues.However, the investigation is inconclusive for the reported difficult to insert issue as the exact circumstances at the time of the reported event are unknown.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.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 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.

• 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: 21215447
• Report Number: 3006260740-2025-00086
• Device Sequence Number: 3377858
• Product Code: MSD
• UDI-Device Identifier: 00801741012174
• UDI-Public: (01)00801741012174(11)240411(17)260131(10)REJP4364
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2025

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: 01/31/2026
• Device Catalogue Number: 5393190
• Device Lot Number: REJP4364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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