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

Catalog Number	5393270
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Unraveled Material (1664); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a dialysis catheter placement procedure, the device allegedly did not pass the guidewire through the puncture needle and allegedly got stuck.It was further reported that the guidewire allegedly broke while attempting to pull it back.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 05/2025) h11: 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
It was reported that during a dialysis catheter placement procedure, the guidewire allegedly could not be passed through the puncture needle and it allegedly became stuck.It was further reported that the guidewire was allegedly difficult to be retracted.Furthermore, the guidewire allegedly broke while attempting to pull it back.The procedure was completed by using another device.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 guidewire segment and one introducer needle were returned for evaluation.Gross visual and microscopic evaluations were performed on the returned device.The guidewire segment returned was noted to be uncoiled.The round core wire was noted to be protruding the proximal portion of the guidewire segment.A complete break was noted to the flat core wire at the proximal end of the guidewire segment loaded in the introducer needle hub.Therefore, the investigation is confirmed for the reported fracture and identified material separation, stretched and unraveled issues.However, the investigation is inconclusive for the reported failure to advance, difficult to remove and the guidewire resistance issues as the functional testing was unable to be performed due to the condition of the sample and as the exact circumstance at the time of the event reported was unknown.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: b5, d4 (expiration date: 05/2025).H11: 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: 18835564
• Report Number: 3006260740-2024-00913
• Device Sequence Number: 20697424
• Product Code: MSD
• UDI-Device Identifier: 00801741012198
• UDI-Public: (01)00801741012198
• 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): 04/18/2024

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 Catalogue Number: 5393270
• Device Lot Number: REHU0525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/24/2024
• 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