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

Model Number 006173P

Device Problems Kinked (1339); Physical Resistance (2578); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.

Event Description

It was reported that there was high resistance through the introducer sheath, which caused difficulty in advancing the pacemaker wires.As a result, the healthcare professional (hcp) was not fast enough to overcome the tricuspid valve with the approximate start-up.While the hcp attempted to advance the wire, there was kinking at the inlet opening of the introducer sheath, so the wire was unable to be pushed forward.It was later reported that the procedure was prolonged, since a new pacemaker wire had to be placed.There was no patient injury or discomfort reported.Clinical statement: the standard time for a pacemaker wire procedure is approximately 1 hour.The procedure is done under local anesthesia which minimizes the potential for complications under anesthesia.(b)(4).(b)(6) 2017.

Manufacturer Narrative

Received 1 electrode catheter in open packaging.The reported event was unconfirmed.The evaluation of the sample noted that the catheter was easily advanced through the unused bard supplied introducer / needle cannula assembly.Included in the returned tray, were the needle cannula, ekg clip, protected pin adapters and the bard syringe, which was attached to the stopcock of the catheter.The complainant did not include the introducer that was used in the field as part of the sample that was returned for evaluation.The introducer used during the procedure was stated to be an arrow sheath (part no.Ik-09600) intended for use with catheter sized 4-6fr.A potential root cause of the reported event according to the fmea is the user was unaware of proper use.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "temporary pacing electrode catheter information for use read this document in its entirety prior to use.Single use.Sterile, non-pyrogenic.Store in a cool, dry place.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Description: bard® temporary pacing catheters are constructed of a woven or extruded polyurethane shaft with platinum or stainless steel electrodes.Certain catheters may incorporate one or more lumens for fluid infusion, pressure monitoring, blood sampling, or balloon inflation.The balloons are manufactured using latex material.Some product may be packaged with accessories such as a needle cannula, safety lead adapter, an ecg adapter, or a balloon inflation syringe.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 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.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, torqueing, 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.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws.Instructions for use: inspection instructions; inspect the sterile package carefully for damage during transit or storage.Do not use the catheter if the package is damaged.Visually inspect the catheter, under sterile conditions, for kinks in the catheter shaft, integrity of the connector, condition of electrodes, and any other damage.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: 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.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 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.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 (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.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." (b)(4).

Event Description

It was reported that there was high resistance through the introducer sheath, which caused difficulty in advancing the pacemaker wires.As a result, the healthcare professional (hcp) was not fast enough to overcome the tricuspid valve with the approximate start-up.While the hcp attempted to advance the wire, there was kinking at the inlet opening of the introducer sheath, so the wire was unable to be pushed forward.It was later reported that the procedure was prolonged, since a new pacemaker wire had to be placed.There was no patient injury or discomfort reported.Clinical statement: the standard time for a pacemaker wire procedure is approximately 1 hour.The procedure is done under local anesthesia which minimizes the potential for complications under anesthesia.

• Brand Name: BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM
• Type of Device: TPE
• 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: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6679804
• MDR Text Key: 78862710
• Report Number: 1018233-2017-03403
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011207
• UDI-Public: (01)00801741011207
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K800298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 006173P
• Device Catalogue Number: 006173P
• Device Lot Number: GFBQ1836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2017
• 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