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

Catalog Number	5343190
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, it was reported that after removing a 13f x19cm glidepath catheter from a patient, the cuff was found to be detached from the catheter.The cuff was subsequently retrieved from the soft tissue, and it was noted that both the cuff and a sleeve portion of the catheter had separated from the original device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records was performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.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) 2025, it was reported that after removing a 13f x 19cm glidepath catheter from a patient, the cuff was found to be detached from the catheter.The cuff was subsequently retrieved from the soft tissue, and it was noted that both the cuff and a sleeve portion of the catheter had separated from the original device.Further probing and dissection with instruments and ultrasound guidance used to visually see and remove the cuff portion.The current status of the patient is unknown.
Additional Manufacturer Narrative
H11: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.As the lot number for the device was provided, a review of the device history records was performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.B5, g3, h1, h6 (patient).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 nov 04, 2025, it was reported that after removing a 13f x 19cm glidepath catheter from a patient, the cuff was found to be detached from the catheter.The cuff was subsequently retrieved from the soft tissue, and it was noted that both the cuff and a sleeve portion of the catheter had separated from the original device.Further probing and dissection with instruments and ultrasound guidance used to visually see and remove the cuff portion.The current status of the patient is unknown.
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, three electronic photos were provided and reviewed.The photos show the complete view of catheter and cuff along with tube were noted to detached from the catheter.Blood residues were noted on the device.Manufacturing review was performed and cuff detachment was verified and confirmed, however in accordance with established manufacturing processes, the component involved is not handled during the assembly stage and as per supplier investigation no trends or evidence of systemic issues related to bonding, materials, or the assembly process have been identified.No potential failure was identified related to manufacturing and supplier related.As per instructions for use (ifu) the catheter must be surgically removed.Free the cuff from the tissue and pull the catheter gently and smoothly."freeing the cuff" was missed during procedure, hence detachment of cuff and tube considered as use related issue.Therefore, the investigation is confirmed for the reported cuff detachment issue and identified improper procedure.The root cause was determined to be use related.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.G3, h6 (device, method, result, conclusion).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.

• 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: 23641577
• Report Number: 3006260740-2025-08988
• Device Sequence Number: 21360804
• Product Code: MSD
• UDI-Device Identifier: 00801741187391
• UDI-Public: (01)00801741187391(11)250215(17)260930(10)REJZ2126
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K211410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 5343190
• Device Lot Number: REJZ2126
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 05/05/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/27/2026; 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 50 KG