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

Catalog Number	007153P
Medical Device Problem Code	No Pacing (3268)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the surgeon said that there was no current output from the temporary pacing electrode after the temporary pacemaker was connected, so a new one was replaced, and it worked.
Additional Manufacturer Narrative
The reported event was unconfirmed.Sample evaluation results: the returned sample was tested for electrical resistance using test box t-657, calibrated 1/13/2025, due 1/2026, multimeter t-402, calibrated 1/13/2025, due 1/2026.Were utilized to test the functionality of both the distal and proximal electrodes.Electrodes look acceptable - no scratches etc.It was observed that glue residue was on electrodes.Sample evaluation conclusions: review of the catheter indicated the complaint is unconfirmed, the complaint sample does not exhibit the failure condition alleged by the complaint.Root cause summary: review of the sample shows the complaint does not exist.The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: review of the sample indicates that the alleged concern does not exist.Both electrodes tested within spec, there was no damage to the catheter.Thus, the complaint is unconfirmed.No root cause could be found because the reported event was unconfirmed.A risk review, a labelling review was required as the reported event was unconfirmed.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Correction: d, e, h 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.
Event or Problem Description
It was reported that the surgeon said that there was no current output from the temporary pacing electrode after the temporary pacemaker was connected, so a new one was replaced, and it worked.

• Brand Name: TEMPORARY PACING ELECTRODE CATHETER
• Common Device Name: 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 20901848
• Report Number: 1018233-2024-07914
• Device Sequence Number: 9052836
• Product Code: LDF
• UDI-Device Identifier: 00801741011290
• UDI-Public: (01)00801741011290(11)230612(17)280630(10)GFHQ2278
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• 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): 04/25/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 007153P
• Device Lot Number: GFHQ2278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 04/26/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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: Other
• Patient Sex: Unknown