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

Catalog Number	006173P
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported multiple issues with the temporary pacing balloon catheter.During use, the yellow pins became detached from the wires.The customer stated that this issue had occurred several times during the doctor's procedures and raised concerns regarding the reliability of the device during critical cardiac interventions.The customer further stated that the malfunction had the potential to compromise patient safety.No patient injury or death was reported.The customer requested recommendations and possible alternative products to help ensure uninterrupted patient care.
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.

• 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 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; +1(770)784-6100
• MDR Report Key: 50208707
• Report Number: 1018233-2026-05294
• Device Sequence Number: 20191816
• Product Code: LDF
• UDI-Device Identifier: 00801741011207
• UDI-Public: (01)00801741011207
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K251186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: 006173P
• 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: 07/30/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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