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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; TEMPORARY PACING ELECTRODE CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM; TEMPORARY PACING ELECTRODE CATHETER Back to Search Results
Catalog Number 006173P
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/11/2023
Event Type  malfunction  
Event Description
It was reported that there was visible damage to the balloon and when they tried to use it, it was not possible to manage the intervention with it.As per the follow up information received on 21sep2023, the customer clarified that the tpe was used on the patient and there was a visible damage on the balloon of the tpe.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
 
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 temporary pacing electrode catheter.Visual inspection of the sample noted the balloon was damaged and burst.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: d, e 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 there was visible damage to the balloon and when they tried to use it, it was not possible to manage the intervention with it.As per the follow up information received on 21sep2023, the customer clarified that the tpe was used on the patient and there was a visible damage on the balloon of the tpe.
 
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Brand Name
BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM
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 Key17870191
MDR Text Key325350495
Report Number1018233-2023-07176
Device Sequence Number1
Product Code LDF
UDI-Device Identifier00801741011207
UDI-Public(01)00801741011207
Combination Product (y/n)N
Reporter Country CodeEZ
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
Report Date 01/17/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number006173P
Device Lot NumberGFHQ0636
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/17/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2023
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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