FDA Adverse Event Death Summary report: N

5 FRENCH BY 110CM TEMPORARY PACING - BALLOON TIP

MDR report key: 3213135 · Received June 21, 2013

Report

Report Number
3213135
Event Type
Death
Date Received
June 21, 2013
Date of Event
June 11, 2013
Report Date
June 20, 2013
Manufacturer
CR BARD MEDICAL
Product Code
LDF
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
TX, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

THE PATIENT IS (B)(6) WOMAN WITH CHIEF COMPLAINT OF SYNCOPE. NOTED TO BE IN COMPLETE HEART BLOCK. TRANSFERRED FROM THE EMERGENCY DEPARTMENT TO THE CARDIAC CATHETERIZATION LABORATORY (CCL) FOR AN EMERGENT TEMPORARY PACEMAKER PLACEMENT. TEMPORARY TRANSVENOUS PACER WIRE INSERTION VIA A 6-FRENCH SHEATH WAS PLACED INTO THE RIGHT FEMORAL VEIN USING A MODIFIED SELDINGER APPROACH. IT WAS PLACED INTO THE RIGHT VENTRICLE UNDER FLUOROSCOPY. THERE WAS GOOD CAPTURE. THIS CASE ENDED AT 15:48. AT 16:43 IN THE INTENSIVE CARE UNIT, THE PATIENT HAD NEAR SYNCOPAL EPISODE AND DEVELOPED SIGNIFICANT BRADYCARDIA. TELEMETRY MONITOR SHOWED TRANSVENOUS PACER WAS NOT CAPTURING. PATIENT BECAME UNRESPONSIVE, ARRESTED AND WAS INTUBATED. RETURNED CCL AT 17:02. THE RIGHT FEMORAL TEMPORARY PACING WIRE WAS REPOSITIONED. CAPTURE OF THE RIGHT VENTRICLE WAS ACHIEVED. DURING THE DRAPING OF THE PATIENT, SHE DEVELOPED SEVERE HYPOTENSION THEN RESUSCITATION. CAPTURE OF THE RIGHT VENTRICLE WAS ACHIEVED. ONE 6-FRENCH SHEATH WAS PLACED IN THE LEFT FEMORAL VEIN USING THE MODIFIED SELDINGER TECHNIQUE. ANOTHER 6-FRENCH SHEATH WAS PLACED IN THE LEFT FEMORAL ARTERY USING THE MODIFIED SELDINGER TECHNIQUE. THE FEMORAL SHEATH WAS USED FOR MONITORING OF HER ARTERIAL BLOOD PRESSURE DIRECTLY. ANOTHER TEMPORARY PACING WIRE WAS ADVANCED VIA THE LEFT FEMORAL VENOUS SHEATH UNDER FLUOROSCOPIC GUIDANCE TO THE RIGHT VENTRICLE FOR BACKUP RIGHT VENTRICULAR PACING SUPPORT. THE PACING WIRE WAS SET UP IN SUCH A WAY THAT THERE IS A SECOND BACKUP TEMPORARY PACING WIRE, IF ONE TEMPORARY PACING WIRE BECOMES DISLODGED FROM ITS ORIGINAL LOCATION. POST SECOND PROCEDURE ANOXIC ENCEPHALOPATHY, NON-ST ELEVATION MI, ACUTE RENAL FAILURE, ACUTE RESPIRATORY FAILURE AND SHOCK. SHE WAS SEEN BY MULTIPLE SUB-SPECIALITIES INCLUDING RENAL, CARDIOLOGY AND INFECTIOUS DISEASE; HOWEVER, SHE REMAINS HYPOTENSIVE AND UNRESPONSIVE. EEG SHOWS GENERALIZED CEREBRAL DYSFUNCTION. ECHO SHOWS SEVERE CARDIOMYOPATHY WITH EF OF 20%. ON (B)(6) 2013, PATIENT EXPIRED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
282403 5 FRENCH BY 110CM TEMPORARY PACING - BALLOON TIP 5 FRENCH BY 110CM TEMPORARY PACING - BALL LDF CR BARD MEDICAL 005856P NA

Patients

Seq Age Sex Outcome Treatment
1 87 YR Death| H| L| R SINGLE CHAMBER PACEMAKER| MEDTRONIC