MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM; BALLOON FLOW-ASSISTED BIPOLAR ELECTRODE CATHETER

Catalog Number 006172P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Sepsis (2067); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/09/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.H3 other text : the device was not returned.

Event Description

It was reported that in the online survey a physician stated that the patient experienced perforation (arterial or cardiac), pericardial effusion, tamponade, infection, sepsis prior to the device placement and pericardial effusion, bleeding, bacterial infection in the groin, sepsis complications were directly attributable to the device and fever was needed for infection, and surgery was needed for sepsis, and cabg was needed for pericardial effusion, and anemia led to transfusion was needed for bleeding in relation to temporary pacing electrode.

Manufacturer Narrative

The reported event is inconclusive because no sample was returned, and further investigation was not conclusive.There have been no changes to the materials used or the manufacturing processes involved with this product.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "read this document in its entirety prior to use." "inappropriate electrical connections, e.G.Into a wall socket, may pose serious risk of adverse health consequences or death." "this device should be used only by or under the supervision of physicians trained in the techniques of transvenous intracardiac studies and temporary pacing." "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." "visually inspect the catheter, under sterile conditions, for kinks in the catheter shaft, integrity of the connector, condition of electrodes, and any other damage." "insertion instructions using a needle cannula: open the package and place the contents on a sterile field.Prep the skin at the site of insertion and inject a local anesthetic.Remove the protective guard from the needle cannula.Enter the vein with the needle cannula.Simultaneous aspiration into a syringe will help confirm vessel entry.Remove the syringe and the needle.If using an open-lumen catheter, flush the catheter with a heparinized solution.Remove any stylette prior to insertion.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.If using a balloon catheter, deflate the balloon after the catheter has reached the desired location.Test the pacing characteristics for optimal pacing.Pull the cannula back and secure it to the proximal end of the catheter.Secure the electrode catheter in place at the insertion site." "electrical connections for measuring intracardiac ecgs: insert adapter pin into standard 2 mm (0.080¿) pin receptacle of equipment.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.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 insert adapter pin into standard 2 mm (0.080¿) pin receptacle of equipment.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.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." 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.H3 other text: the device was not returned.

Event Description

It was reported that in the online survey a physician stated that the patient experienced perforation (arterial or cardiac), pericardial effusion, tamponade, infection, sepsis prior to the device placement and pericardial effusion, bleeding, bacterial infection in the groin, sepsis complications were directly attributable to the device and fever was needed for infection, and surgery was needed for sepsis, and cabg was needed for pericardial effusion, and anemia led to transfusion was needed for bleeding in relation to temporary pacing electrode.

• Brand Name: BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM
• Type of Device: BALLOON FLOW-ASSISTED BIPOLAR 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: 17660867
• MDR Text Key: 322379594
• Report Number: 1018233-2023-06454
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K800298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 006172P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other