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

Catalog Number 5396240

Device Problems Fracture (1260); Difficult to Insert (1316); Stretched (1601); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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.H3 other text : device pending return.

Event Description

It was reported that during a dialysis catheter placement procedure, there was strong resistance felt during inserting the guidewire, after puncturing the needle.It was further reported that the device allegedly broken upon removal.Reportedly, another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one j-tip guidewire, one introducer needle, one guidewire hoop and one needle protector were received for evaluation.Visual and functional evaluations were performed.The proximal portion of the j-tip guidewire was noted to be uncoiled and stretched.The distal portion of the j-tip guidewire was noted to be bent.Therefore, the investigation is confirmed for the identified deformation due to compressive stress and stretched issues.However, the investigation is inconclusive for the reported physical resistance and difficult to insert issues as the exact circumstance at the time of the event reported was unknown.The investigation is also unconfirmed for the reported fracture issue as no fracture was noted.The definitive root cause could not be determined based upon the available 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 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.H3 other text : see h10.

Event Description

It was reported that during a dialysis catheter placement procedure, there was strong resistance felt during inserting the guidewire, after puncturing the needle.It was further reported that the device was allegedly broken upon removal.Reportedly, another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: GLIDEPATH
• Type of Device: 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: 17761954
• MDR Text Key: 323580800
• Report Number: 3006260740-2023-04133
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741012259
• UDI-Public: (01)00801741012259
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5396240
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1