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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 NBIH TEMPORARY PACING ELECTRODE CATHETER; ELECTROSYSTOLIC TRAINING PROBE
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C.R. BARD, INC. (COVINGTON) -1018233 NBIH TEMPORARY PACING ELECTRODE CATHETER; ELECTROSYSTOLIC TRAINING PROBE Back to Search Results
Model Number 007153P
Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Cardiopulmonary Arrest (1765); Death (1802); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Tachycardia (2095); Cardiac Perforation (2513); Pericardial Effusion (3271)
Event Date 02/18/2020
Event Type  Death  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that a patient had a temporary pacing electrode placed on (b)(6) 2020 at approximately 6:30 pm.On (b)(6) 2020, the patient's blood pressure suddenly dropped, and the patient developed tachycardia and went into cardiac arrest.An ultrasound was performed which showed pericardial effusion requiring emergency drainage.A ct scan was also performed which showed that the pericardium was perforated.It was also reported that the patient expired.
 
Event Description
It was reported that a patient had a temporary pacing electrode placed on (b)(6) 2020 at approximately 6:30 pm.On (b)(6) 2020, the patient's blood pressure suddenly dropped, and the patient developed tachycardia and went into cardiac arrest.An ultrasound was performed which showed pericardial effusion requiring emergency drainage.A ct scan was also performed which showed that the pericardium was perforated.It was also reported that the patient expired.
 
Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to "improper material selection".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: "this device should be used only by or under the supervision of physicians trained in the techniques of transvenous intracardiac studies and temporary pacing." 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.H3 other text : the device was not returned.
 
Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to "improper material selection." 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: "this device should be used only by or under the supervision of physicians trained in the techniques of transvenous intracardiac studies and temporary pacing." 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.H3 other text: the device was not returned.
 
Event Description
It was reported that a patient had a temporary pacing electrode placed on (b)(6) 2020 at approximately 6:30 pm.On (b)(6) 2020, the patient's blood pressure suddenly dropped, and the patient developed tachycardia and went into cardiac arrest.An ultrasound was performed which showed pericardial effusion requiring emergency drainage.A ct scan was also performed which showed that the pericardium was perforated.It was also reported that the patient expired.Per additional information received via email on 9apr2020 from the facility.The patient was diagnosed with conduction disorders with recurrent discomfort and was treated with an endovascular electrophysiology study.Per the medical record, the cause of death was cardio-respiratory arrest due to tamponade in connection with the endovascular electrophysiology study.
 
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Brand Name
NBIH TEMPORARY PACING ELECTRODE CATHETER
Type of Device
ELECTROSYSTOLIC TRAINING PROBE
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9832474
MDR Text Key183465152
Report Number1018233-2020-01816
Device Sequence Number1
Product Code LDF
UDI-Device Identifier00801741011290
UDI-Public(01)00801741011290
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup,Followup
Report Date 04/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2023
Device Model Number007153P
Device Catalogue Number007153P
Device Lot NumberGFCP2677
Was Device Available for Evaluation? No
Date Manufacturer Received04/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age79 YR
Patient Weight50
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