MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 TEMPERATURE PACING ELECTRODE

Model Number 006173P

Device Problems Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)

Patient Problem Exposure to Body Fluids (1745)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the temporary pacing electrode catheter was kinked.It was stated that the user was exposed to hazardous, blood, or bodily fluids.Per follow-up information received via ibc on (b)(6) 2023, stated that the device was used on the patient and the patient was exposed to hazardous, blood, or bodily fluids.It is unknown what medical intervention is provided.

Manufacturer Narrative

The reported event is confirmed, cause unknown.The used temporary pacing electrode catheter with luer syringe was returned without the original packaging.No kink was observed, however, a small bend was noted on the shaft of the electrode catheter; this is out of specifications.Though a specific cause cannot be determined, a potential root cause for this event could be, "pulling distal wire to taut at mp5898 (assemble electrodes proximal/distal)".No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.The instructions for use were found adequate and states the following: the temporary pacing electrode catheter information for use, baw5014753 revision 6, was reviewed and found to be adequate as it states: "excessive bending, torquing, or kinking of the electrode catheter may cause damage to the catheter including damage to internal wires." "inspect the sterile package carefully for damage during transit or storage.Do not use the catheter if the package is damaged." "visually inspect the catheter, under sterile conditions, for kinks in the catheter shaft, integrity of the connector, condition of electrodes, and any other damage." 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: the actual/suspected device was inspected.

Event Description

It was reported that the temporary pacing electrode catheter was kinked.It was stated that the user was exposed to hazardous, blood, or bodily fluids.As per follow-up information received via ibc on 10feb2023, stated that the device was used on the patient and the patient was exposed to hazardous, blood, or bodily fluids.

• Brand Name: TEMPERATURE PACING ELECTRODE
• Type of Device: TEMPERATURE PACING ELECTRODE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16440970
• MDR Text Key: 310225004
• Report Number: 1018233-2023-01211
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011207
• UDI-Public: (01)00801741011207
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K800298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 006173P
• Device Catalogue Number: 006173P
• Device Lot Number: GFDX4478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2019
• 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): Other