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

Catalog Number 5393190

Device Problems Fracture (1260); Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Unraveled Material (1664); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

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

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2024) 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 : device pending return.

Event Description

It was reported that during a dialysis catheter placement procedure, the medal needle allegedly had resistance occurred at the tip of the metal needle.It was further reported that the guidewire was allegedly found to be damaged or torn.There was no reported patient injury.

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 segment and one unknown guidewire in a guidewire hoop was returned for evaluation.Gross visual and microscopic evaluations were performed on the returned device.The guidewire segment returned was noted to be uncoiled.The flat core wire was noted to be protruding the proximal portion of the guidewire segment.A complete break was noted to both core wires on the proximal end of the guidewire segment.Therefore, the investigation is confirmed for the identified stretched, fracture, material separation and unraveled issues.However the investigation is inconclusive for the reported difficult to remove and the guidewire resistance issues as the exact circumstance at the time of the event reported was unknown.However the investigation is unconfirmed for the reported material tear issue.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 (expiry date: 03/2024), g3, h6 (device) h11: h6 (method, result, conclusion) 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, the tip of the metal needle allegedly had resistance making it difficult to remove the guidewire.It was further reported that the guidewire was allegedly found to be damaged or torn.The procedure was completed by using another device.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: 18289929
• MDR Text Key: 330020779
• Report Number: 3006260740-2023-05594
• Device Sequence Number: 1
• Product Code: MSD
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5393190
• Device Lot Number: REGT2711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• 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