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

Model Number 006173P

Device Problems Deflation Problem (1149); Gas/Air Leak (2946)

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 was filled normally prior to the procedure and later deflated on its own.

Event Description

It was reported that the balloon on the electrode was filled normally prior to the procedure and later deflated on its own.

Manufacturer Narrative

The event was unconfirmed based on the evaluation.One unopened 023 5f 110cm bipolar bal ele was received.Upon secondary evaluation it was noticed that the package was opened.(gross visual evaluation.)the device was inflated with 1.5ml and then 2ml inflation volume.The stopcock was closed and the balloon was observed for signs of deflation.No leakage or loss of inflation volume was noted.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: ¿read this document in its entirety prior to use.Single use.Sterile, non-pyrogenic store in a cool, dry place.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.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.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.Warnings for heparin bonded catheters ¿ long-term pacing: although the surface of the catheter has been treated with an anticoagulant to minimize thromboembolic complications, the possibility of thromboembolic and infectious complications increases with the length of time of catheterization.The duration of catheterization should, therefore, be limited to the minimum required by the patient's condition.Prophylactic systemic anticoagulant and antibiotic protection should be considered in cases with increased risks and when long-term catheterization (longer then 48 hours) is necessary.The biological activity of the heparin bonding is initiated by blood contact, therefore, efficacy of the bonding is limited to one patient use only.¿ it has been reported that heparin induced thrombocytopenia has, in some cases, been associated with the use of heparin bonded catheters.Patients exhibiting symptoms of thrombocytopenia should be monitored for a marked reduction in platelet count and for the presence of heparin associated antiplatelet antibodies.If the condition is confirmed, the physician must remove the catheter if thrombocytopenia is to be reversed and further complications avoided." 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.

• Brand Name: BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM
• Type of Device: TEMPORARY PACING ELECTRODE WITH BALLOON
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8239446
• MDR Text Key: 132919723
• Report Number: 1018233-2019-00218
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011207
• UDI-Public: (01)00801741011207
• Combination Product (y/n): N
• PMA/PMN Number: K800298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 006173P
• Device Catalogue Number: 006173P
• Device Lot Number: GFCU2836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Date Manufacturer Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1