INTRACARDIAC ECHO CATHETER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-25 for INTRACARDIAC ECHO CATHETER manufactured by Abbott.

Event Text Entries

[87381717] During elective electrophysiology procedure (ablation) please note the following from medical record: attempts to place an ice (intracardiac echo) catheter were made. The catheter always seemed to hang up at the transition between the abdominal ivc and the right atrium. There had been no problems with placing the decapolar and the rv quadripolar catheters prior to this. There were no problems placing the large curl agilis, guiding sheath and dilator over a wire. But despite using the ice catheter ultrasound to visualize the area of hang up and trying to change the curve of the catheter with the adjustments of ap and lr, the ice catheter could not be moved past this point. So the catheter was removed and it became clear that the lr adjustment was not working correctly. It was loose, and multiple turns of the barrel of the lr knob were needed to send the catheter left or right, in either direction of travel. The malfunctioning ice catheter was returned to the abbott staff present and a new ice catheter was obtained which operated normally and was quickly placed into the right atrium without difficulty. Additional documentation from provider: when removed from the patient we found the l to r adjustment was loose and manipulation of it did not move the catheter l or r without a great deal of rotation of the control knob. With a new ice catheter was introduced, introduction to the right atrium was smooth and effortless and quick. Patient later found to have an intraperitoneal bleed thought to be linked to a puncture from defective catheter requiring blood transfusions and icu monitoring. Patient ultimately stabilized and was discharged with no further complications.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5072351
MDR Report Key6889979
Date Received2017-09-25
Date of Report2017-09-21
Date of Event2017-07-11
Date Added to Maude2017-09-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameINTRACARDIAC ECHO CATHETER
Generic NameINTRACARDIAC ECHO CATHETER
Product CodeOBJ
Date Received2017-09-25
Returned To Mfg2017-07-11
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerABBOTT

Device Sequence Number: 1

Brand NameINTRACARDIAC ECHO CATHETER
Generic NameINTRACARDIAC ECHO CATHETER
Product CodeDXK
Date Received2017-09-25
Returned To Mfg2017-07-11
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerABBOTT


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2017-09-25

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