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

Model Number 006173P

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problems Exposure to Body Fluids (1745); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/08/2021

Event Type  Injury  

Event Description

It was reported that the temporary pacing electrode catheter was kinked.The patient was exposed to hazardous, blood, or bodily fluids.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was reported that the temporary pacing electrode catheter was kinked.The patient was exposed to hazardous, blood, or bodily fluids.

Event Description

It was reported that the temporary pacing electrode catheter was kinked.The patient was exposed to hazardous, blood, or bodily fluids.It was unknown what medical intervention was provided.

Manufacturer Narrative

The reported event is inconclusive because the complaint sample was not returned for evaluation and further investigation was not conclusive.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)".The device was used for treatment purposes.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "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 bard 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 bard.H3 other text: the device was not returned.

• Brand Name: TEMPORARY PACING ELECTRODE CATHETER
• Type of Device: TEMPORARY PACING ELECTRODE CATHETER
• 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: 16428102
• MDR Text Key: 310181221
• Report Number: 1018233-2023-01140
• 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,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• 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: GFDX4510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2019
• 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