DURING A AAA+ZBIS PROCEDURE ON AN (B)(6) MALE PATIENT, THE VASCULAR RETRIEVER BROKE 3 CENTIMETERS BEFORE THE DISTAL TIP AFTER CAPTURE OF THE HYDROPHILLIC WIRE GUIDE. AN ATTEMPT WAS MADE TO RETRIEVE THE SEPARATED PORTION WITH A FLEXOR 12 FR; HOWEVER, THE TIP AND SNARES REMAINED IN THE FEMORAL ARTERY. ALL WERE IMMEDIATELY RETRIEVED WITH A FOGARTY DEVICE WITHOUT HARM TO THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
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Patient 1
(B)(4).
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Patient 1
(B)(4). EVENT EVALUATION: A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED. OTHER DOCUMENTATION REGARDING THE MANUFACTURE OF THIS DEVICE WAS REVIEWED. THERE IS NO EVIDENCE TO SUGGEST THAT THE PRODUCT WAS NOT MANUFACTURED TO THE CORRECT SPECIFICATIONS. WITHOUT ADDITIONAL INFORMATION OR THE COMPLAINT DEVICE, NO CONCLUSION CAN BE DRAWN FOR THE CAUSE OF THIS COMPLAINT. BASED ON QUALITY ENGINEERING RISK ASSESSMENT, NO ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME. THE APPROPRIATE INTERNAL PERSONNEL WILL BE NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.
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Patient 1
DURING A AAA+ZBIS PROCEDURE ON AN (B)(6) YEAR OLD MALE PATIENT, THE VASCULAR RETRIEVER BROKE 3 CENTIMETERS BEFORE THE DISTAL TIP AFTER CAPTURE OF THE HYDROPHILIC WIRE GUIDE. AN ATTEMPT WAS MADE TO RETRIEVE THE SEPARATED PORTION WITH A FLEXOR 12 FR; HOWEVER, THE TIP AND SNARES REMAINED IN THE FEMORAL ARTERY. ALL WERE IMMEDIATELY RETRIEVED WITH A FOGARTY DEVICE WITHOUT HARM TO THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.