Model Number 518-062 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Tamponade (2226); Iatrogenic Source (2498); Cardiac Perforation (2513)
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Event Date 02/04/2019 |
Event Type
Injury
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Manufacturer Narrative
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Patient age and weight are unavailable from the site.Device lot# could not be provided by the site.Therefore, expiration date and manufactured date could not be determined.Device was discarded by the site.There was no malfunction of a philips device.Therefore, no evaluation will be performed.
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Event Description
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A (b)(6) representative reported that during a lead management procedure to remove a non-functional right ventricular (rv) lead a spectranetics lead locking device ez 518-062 was utilized.A spectranetics 14fr glidelight and a spectranetics visisheath dilator sheath were also used during the extraction.The rv lead came out safely and patient was stable at completion of extraction.15 minutes later during re-implant, the patient's blood pressure dropped.Blood in pericardium resulted in loss of heart function.Rescue interventions were implemented.A perforation had occurred in the rv apex.It was determined that the passive fixation endotak lead had been unknowingly placed extra-cardiac on implantation, resulting in a small pinhole upon removal of that lead.Physicians believe the adverse event was a result of the original lead implantation positioning.Rescue interventions were successful and the patient was recovering in the hospital at time of last report.
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Manufacturer Narrative
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Patient age provided.Patient weight was unavailable, but the patient''s bmi is 33.5.
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Search Alerts/Recalls
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