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

Catalog Number	5393230
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
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 been returned to the manufacturer for evaluation.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 during a port placement procedure the tip of the guidewire allegedly was stuck and would not come out.It was further reported that there was stretching in the needle.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 j-tip guidewire loaded an introducer needle was received for evaluation.Visual, functional and dimensional evaluations were performed on the returned device.The guidewire was noted to be stuck within the introducer needle.An attempt to advance the j-tip guidewire into the introducer needle was performed and was successful.Resistance was felt during performance as the guidewire felt stuck within the introducer needle.After completely removing the guidewire, the distal portion was noted to be bent and stretched.Therefore, the investigation is confirmed for the reported guidewire stuck, stretched and identified deformation and improper or incorrect procedure issues.However, the investigation is inconclusive for the reported difficult to remove as the exact circumstance at the time of the reported event was unknown.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.The definitive root cause for the reported physical resistance, difficult to remove, stretched and identified deformation issues could not be determined based upon the provided information.However, the user error could have contributed to the identified improper procedure or method used issue.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: g3, h6 (device, component, method) h11: 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.
Event or Problem Description
It was reported that during a port placement procedure the tip of the guidewire allegedly was stuck and would not come out.It was further reported that there was stretching in the needle.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: 21592428
• Report Number: 3006260740-2025-01451
• Device Sequence Number: 15520206
• Product Code: MSD
• UDI-Device Identifier: 00801741012181
• UDI-Public: (01)00801741012181(17)260228(10)REJQ2319
• 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,Followup
• Report Date (Section B): 05/26/2025

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: 02/28/2026
• Device Catalogue Number: 5393230
• Device Lot Number: REJQ2319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 05/28/2025
• 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
• Patient Sex: Unknown