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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM; TEMPEERATURE PACING ELECTRODES
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C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM; TEMPEERATURE PACING ELECTRODES Back to Search Results
Model Number 006173P
Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250); Leak/Splash (1354); Defective Device (2588)
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 leaked water.The device was removed and replaced to rectify the issue.The complainant noted via phone on (b)(6) 2019 that the nursing staff discovered the deflation of the balloon after removing the electrode from the patient.It was also noted that the electrode did not respond like it generally did in the body.
 
Manufacturer Narrative
The reported event was unconfirmed.A temporary pacing electrode catheter was returned.The device was inflated with 5ccs of air using a 10cc luer lock syringe.There was no leakage or bubbles when the catheter was placed underwater.The device was allowed to sit for one minute.The balloon did not deflate.The device was then deflated with no issues.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: ¿ 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.¿ for non heparin bonded catheters only: when wiping down this catheter, use only sterile saline.¿ for those catheters that are heparin bonded, the following precautions apply: anticoagulant bonding: since the surface of the catheter shaft is treated with a heparin bonding, do not wipe the shaft with alcohol, its esters or ethers, or phenol compounds lest the bonding be rubbed off.If wound closure is prolonged, an appropriate topical hemostatic agent should be used to neutralize the effect of any heparin that may have been wiped off at the edge of the wound.Longer compression time at the insertion site may be required.The packaging is designed to avoid crushing of the catheter and to help protect the heparin bonding on the surface of the catheter.The heparin treated surfaces are fragile.As a result, reasonable care should be employed when removing the catheter from the package." 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 leaked water.The device was removed and replaced to rectify the issue.The complainant noted via phone on (b)(6) 2019 that the nursing staff discovered the deflation of the balloon after removing the electrode from the patient.It was also noted that the electrode did not respond like it generally did in the body.
 
Event Description
It was reported that the balloon leaked water.The device was removed and replaced to rectify the issue.The complainant noted via phone on (b)(6) 2019 that the nursing staff discovered the deflation of the balloon after removing the electrode from the patient.It was also noted that the electrode did not respond like it generally did in the body.
 
Manufacturer Narrative
The reported event was unconfirmed.A temporary pacing electrode catheter was returned.The device was inflated with 5ccs of air using a 10cc luer lock syringe.There was no leakage or bubbles when the catheter was placed underwater.The device was allowed to sit for one minute.The balloon did not deflate.The device was then deflated with no issues.The device was then inflated with 5ccs of water using a 10ccs luer lock syringe.There was no leakage.The device was allowed to sit for one minute.It did not deflate.The device was then deflated with no issues.The investigation indicated that the reported issue was not manufacturing or supplier related.Therefore, a device history record review was not required.The instructions for use were found inadequate as it does not contain instructions on whether water or air should be used in the catheter during use.The label will be updated.The instructions for use currently state the following: ¿ 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.¿for non heparin bonded catheters only: when wiping down this catheter, use only sterile saline.¿for those catheters that are heparin bonded, the following precautions apply: anticoagulant bonding: since the surface of the catheter shaft is treated with a heparin bonding, do not wipe the shaft with alcohol, its esters or ethers, or phenol compounds lest the bonding be rubbed off.If wound closure is prolonged, an appropriate topical hemostatic agent should be used to neutralize the effect of any heparin that may have been wiped off at the edge of the wound.Longer compression time at the insertion site may be required.The packaging is designed to avoid crushing of the catheter and to help protect the heparin bonding on the surface of the catheter.The heparin treated surfaces are fragile.As a result, reasonable care should be employed when removing the catheter from the package.".
 
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Brand Name
BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM
Type of Device
TEMPEERATURE PACING ELECTRODES
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8508947
MDR Text Key141805891
Report Number1018233-2019-01923
Device Sequence Number1
Product Code LDF
UDI-Device Identifier00801741011207
UDI-Public(01)00801741011207
Combination Product (y/n)N
PMA/PMN Number
K800298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup,Followup
Report Date 08/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2020
Device Model Number006173P
Device Catalogue Number006173P
Device Lot NumberGFCX0489
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2019
Date Manufacturer Received08/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age86 YR
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