Model Number 007153P |
Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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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)
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Event Date 02/18/2020 |
Event Type
Death
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
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Event Description
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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.
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Event Description
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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.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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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.
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Event Description
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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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Search Alerts/Recalls
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