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

Model Number 520007P

Device Problems Burst Container or Vessel (1074); Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 balloon on the electrode catheter "ruptured." the complainant reported that the device was replaced and there was a delay in the procedure.No additional information is available.

Manufacturer Narrative

The reported event was confirmed, however, the cause is unknown.There was a tear noted in the balloon but there was no other visual defect to note.Using a 10cc luer lock syringe, the balloon was attempted to be inflated with 1.5cc of air.The balloon would not inflate.The syringe was the removed and the filled with air and the device was put in a container of water.The balloon was attempted to be filled again but bubbled came out of the tear in the balloon, confirming the leak.A potential root cause is a high modulus latex in the balloon.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 1.Inspect the sterile package carefully for damage during transit or storage.Do not use the catheter if the package 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.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." h11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that the balloon on the electrode catheter "ruptured." the complainant reported that the device was replaced and there was a delay in the procedure.No additional information is available.

• Brand Name: OEM - BALLOON BIPOLAR TEMPORARY PACING ELECTRODE KIT, 5FR 110CM
• Type of Device: BALLOON ELECTRODE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9083063
• MDR Text Key: 164821024
• Report Number: 1018233-2019-05750
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011535
• UDI-Public: (01)00801741011535
• Combination Product (y/n): N
• PMA/PMN Number: K800298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 520007P
• Device Catalogue Number: 520007P
• Device Lot Number: GFBT3069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Date Manufacturer Received: 10/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1