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

Catalog Number 6393190

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/12/2023

Event Type  Injury  

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.However, a video was provided for review.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 Description

It was reported that two days post dialysis catheter placement, the catheter allegedly had a leak from the extension line below the hub.It was further reported that the catheter allegedly had a crack.Furthermore, the catheter allegedly migrated toward the heart.Reportedly, the catheter was removed and replaced.The current status of the patient was unknown.

Event Description

It was reported that two days post dialysis catheter placement, the catheter allegedly had a leak from the extension line below the hub.It was further reported that the catheter allegedly had a crack in the extension line.Furthermore, a segment of the catheter was allegedly migrated towards the heart.Reportedly, the catheter was removed and replaced.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one 19cm glidepath d/l catheter was returned and one video was received for evaluation.Functional, gross visual, tactile and microscopic visual evaluations was performed.A partial circumferential break was noted 0.4cm from the distal end of the red luer and a complete compound circumferential break was noted at the distal end of the catheter.The edges of the distal end of the compound break were noted to be uneven and rough.An in-house syringe was attached to the red luer and water was noted leaking from the partial circumferential break as well as exiting from the compound break.The video shows an implanted catheter which was noted to have a crack in the red luer below the hub.Blood was noted to be leaking from the cracked area of the red luer extension leg.Therefore, the investigation is confirmed for the reported fracture, material separation and fluid leak issue.However, the investigation is inconclusive for the reported migration issue as no objective evidence of migration was provided for review.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.

• 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: 17264548
• MDR Text Key: 318448091
• Report Number: 3006260740-2023-02788
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741138492
• UDI-Public: (01)00801741138492
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 08/07/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 6393190
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/11/2023
• 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
• Patient Outcome(s): Required Intervention