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

Catalog Number	520007P
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
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 the temporary pacing electrode catheter when attempted to use, balloon would not inflate.
Event or Problem Description
It was reported that the temporary pacing electrode catheter when attempted to use, balloon would not inflate.Per customer follow up received via phone on 18dec2024 scrubber had no issues flushing the temporary pacer but was unable to inflate the balloon.Another temporary pacer was handed off and used instead.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.The investigator used the returned 5ml syringe in an attempt to inflate the balloon with 1.5 ml of air.The investigator noted that the balloon inflated ¿slightly¿ but not inflate fully.(photo) the investigator noted that there was no visible damage to the outside of the shaft, stopcock leg, or bifurcate.The balloon is intact, and the ties meet specification.The balloon was submersed in water; no leaks were observed (meaning what air was in the shaft did not leak).A 0.024¿ mandrel was inserted into the proximal end of the shaft to determine if the inner shaft was occluded (a smaller od mandrel was used, as not to damage the inner wires, or inadvertently cause an occlusion from the investigation.The mandrel went through the entire shaft to the tip of the distal area.However, the investigator noted that there was a ¿tight fit ~10cm from the distal end.The shaft was cut at this location to further review the noted concern.The investigator noted that there was a slight pinch on the shaft after the shaft was cut.The mandrel did go completely to the end of the distal tip, denoting that the inner was not occluded.Investigation summary: the complaint sample does exhibit the failure condition alleged by the complaint.The investigators were unable to determine a root cause for the pinched shaft.There is no manufacturing related cause for the noted complaint.No actions can be taken at this time since a root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and states the following: this product contains natural rubber latex which may cause allergic reactions.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.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.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.Inspect the sterile package carefully for damage during transit or storage.Do not use the catheter if the package is damaged.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 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.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: BALLOON BIPOLAR 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: 20763858
• Report Number: 1018233-2024-07404
• Device Sequence Number: 18289540
• Product Code: LDF
• UDI-Device Identifier: 00801741011535
• UDI-Public: (01)00801741011535(11)240912(17)260930(10)GFJU1605
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K800298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 520007P
• Device Lot Number: GFJU1605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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