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

Catalog Number	5393190
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one 19cm glidepath d/l catheter, one catheter stylet, one tunneler, one guidewire hoop and one j-tip guidewire in a guidewire hoop were received for evaluation.Visual, microscopic and dimensional evaluations were performed on the returned device.Multiple bents and stretching were noted throughout the received j-tip guidewire.Uncoiling was noted throughout the distal portion of the guidewire.Therefore, the investigation is confirmed for the identified guidewire deformation and stretched issues.However, the investigation is inconclusive for the reported stuck, failure to advance and difficult to remove issues as the returned sample was not in proper condition to test for the reported issue.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.
Event or Problem Description
A patient underwent for dialysis catheter placement procedure using glidepath.During the procedure, the guidewire allegedly could not advance beyond front of the stylet and could not remove.Reportedly guidewire and catheter became stuck and were removed together.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: 22858499
• Report Number: 3006260740-2025-06012
• Device Sequence Number: 9230851
• Product Code: MSD
• UDI-Device Identifier: 00801741012174
• UDI-Public: (01)00801741012174(17)260930(10)REJY0047
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2025

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: 09/30/2026
• Device Catalogue Number: 5393190
• Device Lot Number: REJY0047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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