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

Catalog Number	006173P
Medical Device Problem Codes	Dent in Material (2526); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they pre-inflated the balloon and it did inflate but was "crooked".They used the product on the on the patient and the balloon ruptured in the patient.Inquired if it caused harm to the patient and she stated it did not.
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.
Additional Manufacturer Narrative
The reported event was inconclusive.The conditions of the sample did not allow further evaluation.Event description: ¿it was reported that they pre inflated the balloon and it did inflate but was "crooked".They used the product on the on the patient and the balloon ruptured in the patient.Inquired if it caused harm to the patient and she stated it did not.¿ sample evaluation results: the returned sample was not functionally tested due to the condition of the balloon.A visual inspection was performed, and no substantial or out of the ordinary conditions were observed that could be conclusively inferred from the condition of the balloon.This is inconclusive as the sample returned could not be tested for the product failure.This product is 100% inspected for product integrity during the manufacturing process for inflated balloon diameter, balloon symmetry and for any visual defects to the balloon.Investigation summary: the complaint sample does exhibit the failure condition alleged by the complaint.Therefore, the complaint is confirmed.It is possible that patient or procedural issues may have contributed to the alleged event.A review of manufacturing documentation could not be reviewed to indicate if a manufacturing related cause was possible for these events.Dhr was unable to be performed as the lot number is unknown.Corrections made to tab(s) d, f, 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 they pre-inflated the balloon and it did inflate but was "crooked".They used the product on the on the patient and the balloon ruptured in the patient.Inquired if it caused harm to the patient and she stated it did not.

• 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. (GFO); 289 bay road; queensbury GA 12804
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23190408
• Report Number: 1018233-2025-08736
• Device Sequence Number: 21118701
• Product Code: LDF
• UDI-Device Identifier: 00801741011207
• UDI-Public: (01)00801741011207
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K800298
• 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,Followup
• Report Date (Section B): 04/20/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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