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

Model Number 106173P

Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Deformation (2976)

Patient Problems Bradycardia (1751); Death (1802); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 07/23/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the temporary pacing electrode catheter would not stay inflated during a transcatheter aortic valve replacement (tavr) procedure despite locking on the proximal end.The surgeon normally uses catalog number 520007p, which he has used successfully for years, but it is on backorder at this time.He had to use catalog number 106173p as a replacement, which does not have the ¿right heart curvature¿ like the previous catheter he normally uses.The surgeon had to manually place a curve on the distal tip because this catheter was more pointed and sphere-like compared to the other catheter.An (b)(6)-year-old female underwent a scheduled tavr procedure in the cardiovascular intervention lab on (b)(6) 2019 for aortic stenosis.After the procedure was complete, with wires removed and two sheaths remaining, she was transferred to the recovery room.Approximately 45 minutes later, she became bradycardic and hypotensive.She was treated with atropine and vasopressors were started.A bedside echocardiogram showed a small pericardial effusion.The patient continued to deteriorate, and a second bedside echocardiogram showed an increase in the effusion.She was taken to the operating room and an emergent pericardial window was performed.The patient coded and she received atropine, milrinone, epinephrine, bicarbonate and other advanced cardiac life saving medications; however, she was unable to be resuscitated and expired on (b)(6) 2019.The nurse stated the cause of death was related to complications of the tavr procedure.In addition, the nurse reports the surgeon had a second tavr patient who experienced a pericardial effusion and required a pericardial window on the same day after the same replacement device was used in the same manner.

Manufacturer Narrative

The reported event was unconfirmed.A temporary pacing electrode catheter was returned still attached to a remington connector cable.A syringe found was attached to the stopcock and plastic covering was found on the outside of the catheter.The catheter was inflated with 1.5 ccs with the attached syringe.The balloon inflated with no issues.The balloon was placed in water for about a minute with no leaks noted.The sample was then retrieved.The catheter was inflated with 1.5 ccs with the attached syringe.The balloon was watched for 30 seconds.No deflation was noted.The product meet specifications drawing ,balloon note d, "balloon to be capable of model inflation with 1.5 ml of air with no deflation for 30 seconds." 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: 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.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.".

Event Description

It was reported that the temporary pacing electrode catheter would not stay inflated during a transcatheter aortic valve replacement (tavr) procedure despite locking on the proximal end.The surgeon normally uses catalog number 520007p, which he has used successfully for years, but it is on backorder at this time.He had to use catalog number 106173p as a replacement, which does not have the ¿right heart curvature¿ like the previous catheter he normally uses.The surgeon had to manually place a curve on the distal tip because this catheter was more pointed and sphere-like compared to the other catheter.An 84-year-old female underwent a scheduled tavr procedure in the cardiovascular intervention lab on 23jul2019 for aortic stenosis.After the procedure was complete, with wires removed and two sheaths remaining, she was transferred to the recovery room.Approximately 45 minutes later, she became bradycardic and hypotensive.She was treated with atropine and vasopressors were started.A bedside echocardiogram showed a small pericardial effusion.The patient continued to deteriorate, and a second bedside echocardiogram showed an increase in the effusion.She was taken to the operating room and an emergent pericardial window was performed.The patient coded and she received atropine, milrinone, epinephrine, bicarbonate and other advanced cardiac life saving medications; however, she was unable to be resuscitated and expired on (b)(6) 2019.The nurse stated the cause of death was related to complications of the tavr procedure.In addition, the nurse reports the surgeon had a second tavr patient who experienced a pericardial effusion and required a pericardial window on the same day after the same replacement device was used in the same manner.

Manufacturer Narrative

The reported event was unconfirmed.A temporary pacing electrode catheter was returned still attached to a remington connector cable.A syringe found was attached to the stopcock and plastic covering was found on the outside of the catheter.The catheter was inflated with 1.5 ccs with the attached syringe.The balloon inflated with no issues.The balloon was placed in water for about a minute with no leaks noted.The sample was then retrieved.The catheter was inflated with 1.5 ccs with the attached syringe.The balloon was watched for 30 seconds.No deflation was noted.The product meet specifications drawing ,balloon note d, "balloon to be capable of model inflation with 1.5 ml of air with no deflation for 30 seconds." 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: "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.W arning: 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.".

Event Description

It was reported that the temporary pacing electrode catheter would not stay inflated during a transcatheter aortic valve replacement (tavr) procedure despite locking on the proximal end.The surgeon normally uses catalog number 520007p, which he has used successfully for years, but it is on backorder at this time.He had to use catalog number 106173p as a replacement, which does not have the ¿right heart curvature¿ like the previous catheter he normally uses.The surgeon had to manually place a curve on the distal tip because this catheter was more pointed and sphere-like compared to the other catheter.An 84-year-old female underwent a scheduled tavr procedure in the cardiovascular intervention lab on (b)(6) 2019 for aortic stenosis.After the procedure was complete, with wires removed and two sheaths remaining, she was transferred to the recovery room.Approximately 45 minutes later, she became bradycardic and hypotensive.She was treated with atropine and vasopressors were started.A bedside echocardiogram showed a small pericardial effusion.The patient continued to deteriorate, and a second bedside echocardiogram showed an increase in the effusion.She was taken to the operating room and an emergent pericardial window was performed.The patient coded and she received atropine, milrinone, epinephrine, bicarbonate and other advanced cardiac life saving medications; however, she was unable to be resuscitated and expired on (b)(6) 2019.The nurse stated the cause of death was related to complications of the tavr procedure.In addition, the nurse reports the surgeon had a second tavr patient who experienced a pericardial effusion and required a pericardial window on the same day after the same replacement device was used in the same manner.Per additional information received on 24sep2019, the patient's cause of death per the death certificate was cardiac arrest due to tamponade as a consequence of aortic stenosis.

• Brand Name: BALLOON BIPOLAR TEMPORARY PACING ELECTRODE
• Type of Device: TEMPORARY PACING ELECTRODE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8903688
• MDR Text Key: 154683384
• Report Number: 1018233-2019-04859
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011573
• UDI-Public: (01)00801741011573
• Combination Product (y/n): N
• PMA/PMN Number: K800298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 106173P
• Device Catalogue Number: 106173P
• Device Lot Number: GFDR0478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 84 YR