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

Model Number 007406P

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

Patient Problems Atrial Fibrillation (1729); Cardiac Tamponade (2226)

Event Date 12/29/2022

Event Type  Death  

Event Description

It was reported that following transcatheter implantation of an aortic valve, the patient experienced an atrioventricular block, and a temporary pacing electrode (tpe) catheter was placed.The tpe catheter used was a larger caliber than usual (context of laboratory rupture).A 7f was used instead of the usual 5f, but the patient was okay at the time of discharge from the block.There was tamponade at day 1 following the transcatheter implantation of the aortic valve with presence of a fibrillation artiale droite (af d; right-sided atrial fibrillation) breach.The patient was transferred to the operating room 3 hours later for the removal of the probe and treatment.There was an unfavorable situation on (b)(6) 2022 at 7 pm, and the patient expired.It was reported that a potential cause of the patient¿s death was related to the stimulation probe.7f stimulation probes are no longer used at this facility.Per additional information received via email from the international business centers (ibc) on 03-feb-2023, it was reported that the device seemed very rigid to the surgeon.Additional clinical follow up information was received via email on 23-feb-2023 from the ibc.Following the transcatheter implantation of an aortic valve, the patient experienced the onset of high-grade atrioventricular block, and a tpe catheter was placed.A 7f catheter had to be used because the facility did not have any 5f tpe catheters available.A 7f was obtained for use from another establishment.Following placement of the tpe catheter, the patient was discharged to the intensive care unit (icu).Several hours after the device was placed, the patient experienced the onset of shock with tamponade, which required emergency bypass surgery for repair of a 2cm right ventricular wound.On (b)(6) 2022, the patient expired, and the death was reported as a result of multivisceral failure at day 1.The following is listed as the cause of death on the patient¿s death certificate: occurrence of tamponade, emergency surgical drainage, refractory shock complicated by polyvisceral failure, asystole.

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 following transcatheter implantation of an aortic valve, the patient experienced an atrioventricular block, and a temporary pacing electrode (tpe) catheter was placed.The tpe catheter used was a larger caliber than usual (context of laboratory rupture).A 7f was used instead of the usual 5f, but the patient was okay at the time of discharge from the block.There was tamponade at day 1 following the transcatheter implantation of the aortic valve with presence of a fibrillation artiale droite (af d; right-sided atrial fibrillation) breach.The patient was transferred to the operating room 3 hours later for the removal of the probe and treatment.There was an unfavorable situation on (b)(6) 2022 at 7 pm, and the patient expired.It was reported that a potential cause of the patient¿s death was related to the stimulation probe.7f stimulation probes are no longer used at this facility.Per additional information received via email from the international business centers (ibc) on 03-feb-2023, it was reported that the device seemed very rigid to the surgeon.Additional clinical follow up information was received via email on 23-feb-2023 from the ibc.Following the transcatheter implantation of an aortic valve, the patient experienced the onset of high-grade atrioventricular block, and a tpe catheter was placed.A 7f catheter had to be used because the facility did not have any 5f tpe catheters available.A 7f was obtained for use from another establishment.Following placement of the tpe catheter, the patient was discharged to the intensive care unit (icu).Several hours after the device was placed, the patient experienced the onset of shock with tamponade, which required emergency bypass surgery for repair of a 2cm right ventricular wound.On (b)(6) 2022, the patient expired, and the death was reported as a result of multivisceral failure at day 1.The following is listed as the cause of death on the patient¿s death certificate: occurrence of tamponade, emergency surgical drainage, refractory shock complicated by polyvisceral failure, asystole.Per additional clinical follow up information received via email on 16-mar-2023 from the ibc, there were no difficulties encountered while inserting the tpe device into the right ventricular point.The patient later experienced tamponade due to a 2cm right ventricular wound.It was reported the wound possibly occurred due to both the rigidity and size of the tpe device.

Manufacturer Narrative

The reported event is inconclusive because no sample was returned and further investigation was not conclusive.Although a specific cause cannot be determined, based on the risk document potential root causes could be, "materials of construction are not biocompatible", "user error", "moisture from water test (mp5709) and flush", "splice bands / circuit wires touching within mold, circuit wires touching within shaft", "improper splice / improper contact between circuit wire and electrodes", "short at slot", "operator error".The device was used for treatment purposes.As the device was not returned it was unknown if it had met all relevant specifications or resulted in the reported event.No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.The instructions for use were found adequate and states the following: "the temporary pacing electrode catheter information for use, (b)(6) revision 8, was reviewed and found to be adequate as it states: "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 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." "electrical connections for measuring intracardiac ecgs 1.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.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.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 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: NBIH¿ TEMPORARY PACING ELECTRODE CATHETER
• Type of Device: TEMPORARY PACING 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: 16459065
• MDR Text Key: 310412280
• Report Number: 1018233-2023-01306
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011368
• UDI-Public: (01)00801741011368
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 007406P
• Device Catalogue Number: 007406P
• Device Lot Number: GFFY0899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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): Death
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 92 KG