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

Catalog Number	006172P
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
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 before use the temporary pacing electrode catheter was found faulty during a very sensitive heart valve implant case.The yellow bit should be sealed to the black bit, but the tech finds out during the procedure it was loose and luckily it did happen just before deploying the heart valve into the patient.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Review of the catheter and associated components indicated the complaint is confirmed, as the safety adapters when attached to the distal tail there was a ¿loose¿ fit.Review of the iqc packets confirmed that the components used to produce the lot in scope of this investigation meet specification requirements and the complaint is not related to manufacturing.No additional actions can be taken at this time since root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: ¿indications for use: bard® temporary pacing catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.When an internal lumen is present (other than the one used for balloon inflation), it may be used for fluid infusion, pressure monitoring, or blood sampling.Warnings.General warnings: these warnings apply to all bard® temporary pacing electrode catheters.Inappropriate electrical connections, e.G.Into a wall socket, may pose serious risk of adverse health consequences or death.Please ensure that the catheter is connected as recommended for pacing or measuring intracardiac electrograms.This device should be used only by or under the supervision of physicians trained in the techniques of transvenous intracardiac studies and temporary pacing.This device is for one time use only.Reuse or resterilization can impair the structural integrity and/or performance of the catheter.Adverse patient reactions can also result from reuse.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.The risks of using temporary pacing catheters include those risks related to heart catheterization, such as thromboembolism, perforation, tamponade, and infection.The induction of an unintended arrhythmia is a known complication.Warning for open lumen temporary pacing electrode catheters: if using an open lumen catheter, remove any guidewire/ stylette prior to electrical stimulation.Warnings for balloon temporary pacing electrode catheters: do not inflate balloon beyond stated maximum inflation capacity of 1.5 ml.Balloon must be completely deflated before withdrawal of the electrode catheter.If the balloon catheter has been inflated in vivo for more than one minute, completely deflate the balloon and reinflate it to the recommended capacity of 1.5 ml.This is recommended because carbon dioxide diffuses through the latex balloon.Precautions: excessive bending, torquing, or kinking of the electrode catheter may cause damage to the catheter including damage to internal wires.When using a balloon catheter, use care when removing the protective sleeve from the distal portion of the catheter.Forced removal of this protective sleeve may result in damage to the balloon and the catheters structural integrity.When wiping down this catheter, use only sterile saline.¿ 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 before use the temporary pacing electrode catheter was found faulty during a very sensitive heart valve implant case.The yellow bit should be sealed to the black bit, but the tech finds out during the procedure it was loose and luckily it did happen just before deploying the heart valve into the patient.

• 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 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: 20566682
• Report Number: 1018233-2024-06874
• Device Sequence Number: 15323793
• Product Code: LDF
• UDI-Device Identifier: 00801741011191
• UDI-Public: (01)00801741011191(11)240501(17)260331(10)GFJQ2094
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/06/2025

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 006172P
• Device Lot Number: GFJQ2094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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