CARDIAC RETRACTION CLIP
Received Apr 21, 2011
Report 2184009-2011-00023 · MDR key 2076025
Device
Product problems
- Device, or device fragments remain in patient
Patient
UNK
- Unknown (for use when the patient's condition is not known)
Narrative
Additional Manufacturer Narrative
(B)(4): ANALYSIS: NO PRODUCT WILL BE RETURNED FOR ANALYSIS. ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION. IT WAS REPORTED FROM RISK MANAGEMENT AT THE HOSPITAL THAT NO FURTHER INFORMATION WOULD BE PROVIDED; THEREFORE, LOT NUMBER IS UNKNOWN, AND NO DEVICE HISTORY CAN BE PERFORMED. CONCLUSION: BASED ON THE LIMITED INFORMATION AVAILABLE, THE PRODUCT WAS INADVERTENTLY LEFT IN THE PATIENT. THIS IS A USER RELATED ISSUE AND NOT RELATED TO THE PERFORMANCE OF THE CLIP. NO FURTHER INFORMATION WILL BE PROVIDED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
MEDTRONIC RECEIVED INFORMATION THAT THIS CORONARY ARTERY RETRACTION CLIP WAS INADVERTENTLY LEFT INSIDE A PATIENT DURING A CABG PROCEDURE PERFORMED IN (B)(6) 2011. IT WAS REPORTED THAT THE CLIP MAY HAVE BEEN SOMEWHERE NEXT TO THE HEART IN THE PERICARDIUM. THE RISK MANAGEMENT GROUP AT THE HOSPITAL INFORMED MEDTRONIC THAT THEY WOULD BE HANDLING THE CASE INTERNALLY AND WOULD NOT RELEASE FURTHER INFORMATION.