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

Catalog Number 006173P

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 10/14/2023

Event Type  malfunction  

Event Description

It was reported that the temporary pacing electrode catheter became dislodged or failed.It required removal and replacement, external pacing.

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.

Manufacturer Narrative

The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be ¿improper latex balloon composition/improper latex balloon wall thickness/improper inflation volume".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: " caution: federal law restricts this device to sale by or on the order by physician.This product contain natural latex rubber which may causes allergic reaction.Warning: these warning apply to all bard temporary pacing electrode catheters.Please ensure that the catheter is connected as recommended for pacing or measuring intracardiac electrogram.This device should be used inly by or under the supervision of physicians trained in the technique of intracardiac studies and temporary pacing.Warning for open lumen temporary pacing electrode.Instruction for use: 1.Inspect the sterile package carefully for damage during transit or storage, do not use the catheter if the package is damaged.2.Visually inspect the catheter under sterile condition for kinks in the catheter shaft integrity of the connector, condition of electrodes and any other damage.3.In case of catheter with a balloon under sterile condition remove the protective sheath and inflate the balloon with 1.5 mil of air or carbon dioxide.Use the inflation syringe included in the package.Completely deflate the balloon after the test." 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 became dislodged or failed.It required removal and replacement, external pacing.

• 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: 18383566
• MDR Text Key: 331214330
• Report Number: 1018233-2023-09143
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011207
• UDI-Public: (01)00801741011207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K800298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 006173P
• Device Lot Number: GFGV1613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 05/21/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2022
• 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