MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 Balloon Bipolar Temporary Pacing Electrode Catheter

Catalog Number	006173P
Medical Device Problem Codes	Nonstandard Device (1420); No Pacing (3268)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during use the introducer performed as expected and was not associated with the incident.The malfunction was traced to the temporary pacing lead.The pacemaker generator and extension cable were replaced and tested in various combinations; however, the issue remained unresolved.The problem was ultimately resolved after replacing the pacing lead inserted into the patient, after which normal function was restored.During the initial use of the defective pacing lead, the patient developed asystole.External pacing had to be initiated, and the patient required sedation with medication boluses.For these frail elderly patient, the resulting complication and increased complexity of treatment caused harm.
Event or Problem Description
It was reported that during use the introducer performed as expected and was not associated with the incident.The malfunction was traced to the temporary pacing lead.The pacemaker generator and extension cable were replaced and tested in various combinations; however, the issue remained unresolved.The problem was ultimately resolved after replacing the pacing lead inserted into the patient, after which normal function was restored.During the initial use of the defective pacing lead, the patient developed asystole.External pacing had to be initiated, and the patient required sedation with medication boluses.For these frail elderly patients, the resulting complication and increased complexity of treatment caused harm.Per follow up information received on 08sep2026, stated that the introducer performed as expected and was not associated with the incident.The malfunction was traced to the temporary pacing lead.The pacemaker generator and extension cable were replaced and tested in various combinations; however, the issue remained unresolved.The problem was ultimately resolved after replacing the pacing lead inserted into the patient, after which normal function was restored.During the initial use of the defective pacing lead, the patient developed asystole.External pacing had to be initiated, and the patient required sedation with medication boluses.For these frail elderly patients, the resulting complication and increased complexity of treatment caused harm.
Additional Manufacturer Narrative
Initial reporter phone number: (b)(6).The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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.
Additional Manufacturer Narrative
The initial reporter's phone number: (b)(6).The reported event was inconclusive because the investigation did not result in any additional findings and no sample was available for evaluation.Product labeling was reviewed for this investigation.Instructions for use inspection instructions 1.Visually inspect the catheter, under sterile conditions, for kinks in the catheter shaft, integrity of the connector, condition of electrodes, and any other damage.2.In case of catheters with a balloon, under sterile conditions, remove the protective sheath and inflate the balloon with 1.5 ml of air or carbon dioxide.Use the inflation syringe included in the package.Completely deflate the balloon after the test.Insertion instructions using a needle cannula.1.Open the package and place the contents on a sterile field.2.Prep the skin at the site of insertion and inject with a local anesthetic.3.Remove the protective guard from the needle cannula.4.Enter the vein with the needle cannula.Simultaneous aspiration into a syringe will help confirm vessel entry.5.Remove the syringe and the needle.6.Using the aid of fluoroscopy or an ecg monitor, advance the catheter through the cannula to the desired position.If using a balloon catheter, inflate the balloon when the catheter is in the right atrium.Please note that the balloon can be inflated or deflated only when the stopcock is parallel to the catheter shaft.Do not pull the catheter back through the cannula as it may cause damage to the catheter.7.If using a balloon catheter, deflate the balloon after the catheter has reached the desired location.8.Test the pacing characteristics for optimal pacing.9.Pull the cannula back and secure it to the proximal end of the catheter.10.Secure the electrode catheter in place at the insertion site.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Corrections: b, d, f, g, h.Udi format updated with available product information per gudid.H11: sections 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: Balloon Bipolar Temporary Pacing Electrode Catheter
• Common Device Name: Temporary Pacing Electrode Catheter
• Manufacturer (Section D): C.R. Bard Inc. (Covington) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. Bard Inc. (Covington) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; +1(770)784-6100
• MDR Report Key: 50408862
• Report Number: 1018233-2026-05540
• Device Sequence Number: 16074622
• Product Code: LDF
• UDI-Device Identifier: 00801741011207
• UDI-Public: (01)00801741011207(11)251021(17)270928(10)GFKW0288
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K800298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 006173P
• Device Lot Number: GFKW0288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown