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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM; BALLOON FLOW-ASSISTED BIPOLAR ELECTRODE CATHETER Back to Search Results
Model Number 006173P
Device Problems Pacing Problem (1439); No Pacing (3268)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 05/11/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that, the intracardiac electrode displacement was ruled out.It was said that it might be caused by poor pacemaker electrode contact and poor pacing.A slight improvement was made after adjustment of the electrodes at the end of the pacemaker.
 
Manufacturer Narrative
The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to ¿improper material selection.¿ the device can be used for the treatment or diagnosis.As the event states to allege that the device was attached to an external pacemaker and was having pacing issues, the device was likely used for the treatment.As no sample was returned it could not be determined whether the device had met specifications or if there was a relationship between the reported event and the device.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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.Contraindications: none.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 trans venous 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/ stylets 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.Warnings for heparin bonded catheters: long-term pacing: although the surface of the catheter has been treated with an anticoagulant to minimize thromboembolic complications, the possibility of thromboembolic and infectious complications increases with the length of time of catheterization.The duration of catheterization should, therefore, be limited to the minimum required by the patient's condition.Prophylactic systemic anticoagulant and antibiotic protection should be considered in cases with increased risks and when long-term catheterization (longer then 48 hours) is necessary.The biological activity of the heparin bonding is initiated by blood contact, therefore, efficacy of the bonding is limited to one patient use only.It has been reported that heparin induced thrombocytopenia has, in some cases, been associated with the use of heparin bonded catheters.Patients exhibiting symptoms of thrombocytopenia should be monitored for a marked reduction in platelet count and for the presence of heparin associated antiplatelet antibodies.If the condition is confirmed, the physician must remove the catheter if thrombocytopenia is to be reversed and further complications avoided.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.For non heparin bonded catheters only: when wiping down this catheter, use only sterile saline.For those catheters that are heparin bonded, the following precautions apply: anticoagulant bonding: since the surface of the catheter shaft is treated with a heparin bonding, do not wipe the shaft with alcohol, its esters or ethers, or phenol compounds lest the bonding be rubbed off.If wound closure is prolonged, an appropriate topical hemostatic agent should be used to neutralize the effect of any heparin that may have been wiped off at the edge of the wound.Longer compression time at the insertion site may be required.The packaging is designed to avoid crushing of the catheter and to help protect the heparin bonding on the surface of the catheter.The heparin treated surfaces are fragile.As a result, reasonable care should be employed when removing the catheter from the package.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 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 stylets 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." h11:section a through f - the information provided by bd represents all of 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 the intracardiac electrode displacement was ruled out.It was noted that it might be caused by poor pacemaker electrode contact and poor pacing.A slight improvement was made after the adjustment of the electrodes at the end of the pacemaker.
 
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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 GA 30014
MDR Report Key10184880
MDR Text Key199473513
Report Number1018233-2020-04020
Device Sequence Number1
Product Code LDF
UDI-Device Identifier00801741011207
UDI-Public(01)00801741011207
Combination Product (y/n)N
PMA/PMN Number
K800298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 09/03/2020
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
Device Operator Health Professional
Device Expiration Date09/30/2021
Device Model Number006173P
Device Catalogue Number006173P
Device Lot NumberGFDW0750
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/31/2020
Initial Date FDA Received06/23/2020
Supplement Dates Manufacturer Received08/14/2020
Supplement Dates FDA Received09/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age75 YR
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