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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 CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER Back to Search Results
Model Number 006173P
Device Problems Burst Container or Vessel (1074); Inflation Problem (1310); Failure to Infuse (2340)
Patient Problem Exposure to Body Fluids (1745)
Event Date 04/21/2023
Event Type  Injury  
Event Description
It was reported that the balloon of the temporary pacing electrode catheter at the tip was unable to be inflated.Stated that the user was exposed to hazardous, blood, or bodily fluids.Medical intervention was unknown.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
 
Manufacturer Narrative
The reported event was confirmed cause unknown.1sample were confirmed to exhibit the reported failure.The device had not met specifications.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (with original packaging), used temperature pacing electrode catheter.Visual inspection of the sample noted some residue on the tip of the catheter.The balloon was noted to be burst with no apparent missing pieces, preventing it from being inflated.A potential root cause for this failure mode could be ¿contaminants, latex defects or abrasion of balloon after attachment to shaft, windows or inclusions over stretched balloon.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 state the following: "excessive bending, torquing, or kinking of the electrode catheter may cause damage to the catheter including damage to internal wires.Inspect the sterile package carefully for damage during transit or storage.Do not use the catheter if the package is damaged.Visually inspect the catheter, under sterile conditions, for kinks in the catheter shaft, integrity of the connector, condition of electrodes, and any other damage." correction: b,d,f,h 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.H3 other text : the actual/suspected device was inspected.
 
Event Description
It was reported that the balloon of the temporary pacing electrode catheter at the tip was unable to be inflated.Stated that the user was exposed to hazardous, blood, or bodily fluids.Medical intervention was unknown.
 
Manufacturer Narrative
The reported event was confirmed cause unknown.1sample were confirmed to exhibit the reported failure.The device had not met specifications.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (with original packaging), used temperature pacing electrode catheter.Visual inspection of the sample noted some residue on the tip of the catheter.The balloon was noted to be burst with no apparent missing pieces, preventing it from being inflated.A potential root cause for this failure mode could be ¿contaminants, latex defects or abrasion of balloon after attachment to shaft, windows or inclusions over stretched balloon.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 state the following: "excessive bending, torquing, or kinking of the electrode catheter may cause damage to the catheter including damage to internal wires.Inspect the sterile package carefully for damage during transit or storage.Do not use the catheter if the package is damaged.Visually inspect the catheter, under sterile conditions, for kinks in the catheter shaft, integrity of the connector, condition of electrodes, and any other damage." 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 Description
It was reported that the balloon of the temporary pacing electrode catheter at the tip was unable to be inflated.Stated that the user was exposed to hazardous, blood, or bodily fluids.Medical intervention was unknown.
 
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Brand Name
BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER
Type of Device
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 Key16952177
MDR Text Key315447177
Report Number1018233-2023-03443
Device Sequence Number1
Product Code LDF
UDI-Device Identifier00801741011207
UDI-Public(01)00801741011207
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K800298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 10/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number006173P
Device Catalogue Number006173P
Device Lot NumberGFGX2607
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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