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

Catalog Number	007153P
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that there had been a back order of temporary pacer insertion kit with 5 fr balloon tip pacing wire or catheter.Materials replaced with the argon sheath kit (6 fr) and a 6 fr pacing catheter or wire, not a balloon tip.For an emergency bedside insertion on progressive care unit, the physician went to insert the catheter or pacing wire, and it did not have a balloon tip that assisted with floating, advancing the catheter into the right ventricle when not in the catheter lab under fluro.The non-balloon tip catheters were more difficult to insert.The cardiac surgery intensive care unit staff came to assist and were unaware that these replacement items were being stocked.Also noted in some of the units the temporary pacing catheters were 6 fr, and this would not fit through the 6 fr sheath.
Event or Problem Description
It was reported that there had been a back order of temporary pacer insertion kit with 5 fr balloon tip pacing wire or catheter.Materials replaced with the argon sheath kit (6 fr) and a 6 fr pacing catheter or wire, not a balloon tip.For an emergency bedside insertion on progressive care unit, the physician went to insert the catheter or pacing wire, and it did not have a balloon tip that assisted with floating, advancing the catheter into the right ventricle when not in the catheter lab under fluro.The non-balloon tip catheters were more difficult to insert.The cardiac surgery intensive care unit staff came to assist and were unaware that these replacement items were being stocked.Also noted in some of the units the temporary pacing catheters were 6 fr, and this would not fit through the 6 fr sheath.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be ¿incorrect dimensions or material selected".However, there was insufficient information to confirm this potential root cause.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: description bard temporary pacing catheters are constructed of a woven or extruded polyurethane shaft with stainless steel electrodes.Certain catheters may incorporate one or more lumens for 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.Clinical benefit the intended clinical benefit of temporary pacing catheters, when connected to an external pulse generator, is to aid in temporary resolution of cardiac pacing abnormalities.The intended clinical benefit of temporary pacing catheters, when connected to a monitoring device, is to aid in clinical management by allowing for temporary cardiac monitoring.Temporary pacing catheters may provide these intended clinical benefits until the need for temporary cardiac pacing / monitoring resolves or until long-term therapy can be initiated.Patient population temporary pacing catheters are used for patients requiring temporary resolution of cardiac pacing abnormalities or temporary cardiac monitoring, until the need for temporary cardiac pacing / monitoring resolves or until long-term therapy can be initiated, as determined by the physician.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.Intended purpose bard temporary pacing electrode catheters are used for temporary resolution of cardiac pacing abnormalities or temporary cardiac monitoring, until the need for temporary cardiac pacing / monitoring resolves or until long-term therapy can be initiated, as determined by the physician.Intended users this device should be used only by or under the supervision of physicians trained in the techniques of transvenous intracardiac studies and temporary pacing.Intended lifetime of use the intended lifetime of use for bard temporary pacing catheters and the introducer catheter (cannula) is up to 11 days.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.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.After initial insertion of the needle, do not attempt to reinsert once partially or completely withdrawn.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.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.This product contains natural rubber latex which may cause allergic reactions.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.When wiping down this catheter, use only sterile saline.Instructions for use inspection instructions 1.Visually inspect the catheter, under sterile conditions, for kinks in the catheter shaft, integrity of the connector, condition of electrodes, and any other damage.2.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 with 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.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.7.If using a balloon catheter, deflate the balloon after the catheter has reached the desired location.8.Test the pacing characteristics for optimal pacing.9.Pull the cannula back and secure it to the proximal end of the catheter.10.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.Udi format updated with available product information per gudid.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
• Common Device Name: 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: 19918282
• Report Number: 1018233-2024-04693
• Device Sequence Number: 8104108
• Product Code: LDF
• UDI-Device Identifier: 00801741011290
• UDI-Public: (01)00801741011290
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 007153P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown