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

Catalog Number	006172P
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
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 it was already pointed out to in a previous email that yes, the patient has suffered harm and was not the only one.The problem had persisted since last year.A report had already been made to the pharmacy department and had removed the defective yellow connectors from our service so that it would no longer have this problem.The prejudice was that in the event of an emergency need for cardiac stimulation, the current assembly with defective yellow connectors did not allow the stimulation to be delivered.As pointed out to in a previous email, the customer cannot provide with a batch number, because these electrodes were reused several times.Per follow up information received via ibc on 01apr2025, stated that the tracking information would be provided when the sample will be ready for the shipment, the batch of material sent cannot be supplied to you, as it was already reused electrodes; at the time of the incident, the patient did not suffer any physical injury, but the treatment took longer and was there for few seconds without a cardiac stimulus till the time it took to find other electrodes kept in the room and change them and the event that triggered this report occurred on (b)(6) 2025 but several events have occurred and each time it was the same problem and the same solution that the defective electrodes are discarded and others are used to replace them.
Event or Problem Description
It was reported that it was already pointed out to in a previous email that yes, the patient has suffered harm and was not the only one.The problem had persisted since last year.A report had already been made to the pharmacy department and had removed the defective yellow connectors from our service so that it would no longer have this problem.The prejudice was that in the event of an emergency need for cardiac stimulation, the current assembly with defective yellow connectors did not allow the stimulation to be delivered.As pointed out to in a previous email, the customer cannot provide with a batch number, because these electrodes were reused several times.Per follow up information received via ibc on 01apr2025, stated that the tracking information would be provided when the sample will be ready for the shipment, the batch of material sent cannot be supplied to you, as it was already reused electrodes; at the time of the incident, the patient did not suffer any physical injury, but the treatment took longer and was there for few seconds without a cardiac stimulus till the time it took to find other electrodes kept in the room and change them and the event that triggered this report occurred on (b)(6) 2025 but several events have occurred and each time it was the same problem and the same solution that the defective electrodes are discarded and others are used to replace them.
Additional Manufacturer Narrative
The reported event was inconclusive because the investigation did not result in any additional findings and no sample was available for evaluation.No actions can be taken at this time since a root cause was not identified.The device history record review could not be performed without a lot number.The instructions for use were found adequate and state the following: instructions for use inspection instructions 1.Inspect the sterile package carefully for damage during transit or storage.Do not use the catheter if the package is damaged.2.Visually inspect the catheter, under sterile conditions, for kinks in the catheter shaft, integrity of the connector, condition of electrodes, and any other damage.3.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 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.If using an open-lumen catheter, flush the catheter with a heparinized solution.Remove any stylette prior to insertion.7.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.8.If using a balloon catheter, deflate the balloon after the catheter has reached the desired location.9.Test the pacing characteristics for optimal pacing.10.Pull the cannula back and secure it to the proximal end of the catheter.11.Secure the electrode catheter in place at the insertion site.Insertion instructions using a percutaneous introducer sheath follow the instructions, warnings, and precautions of the introducer manufacturer.If using a balloon temporary pacing catheter, use half or one french size larger introducer, unless otherwise recommended by the introducer manufacturer.Electrical connections for measuring intracardiac ecgs 1.Insert adapter pin into standard 2 mm (0.080) pin receptacle of equipment (see figure 1).If equipment contains a locking mechanism such as a collet or thumbscrew, tighten down onto adapter.Leave affixed to equipment.Warning: inappropriate electrical connections, e.G.Into a wall socket, may pose serious risk of adverse health consequences or death.2.Thread leads of catheter through the adapter eyelet.Connect the negative jack (marked distal) to the v-lead of the ecg, and the positive jack (unmarked) to the positive terminal of the external pulse generator.Electrical connections for pacing 1.Insert adapter pin into standard 2 mm (0.080) pin receptacle of equipment (see figure 1).If equipment contains a locking mechanism such as a collet or thumbscrew, tighten down onto adapter.Leave affixed to equipment.Warning: inappropriate electrical connections, e.G.Into a wall socket, may pose serious risk of adverse health consequences or death.2.Thread leads of catheter through the adapter eyelet.Connect the negative jack (marked distal) to the negative terminal of the external pulse generator, and the positive jack (unmarked) to the positive terminal of the pulse generator.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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21806407
• Report Number: 1018233-2025-02483
• Device Sequence Number: 13014130
• Product Code: LDF
• UDI-Device Identifier: 00801741011191
• UDI-Public: (01)00801741011191
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K800298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 006172P
• 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: 03/21/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 04/23/2025
• 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