COMPLAINT # (B)(4). IT WAS REPORTED THAT THE PT HAD IMPAIRED CONSCIOUSNESS AND WAS TRANSPORTED TO THE EMERGENCY ROOM WHERE A CATHETER WAS PLACED FOR BLADDER DRAINAGE. FOLLOWING A CT TEST REVEALED THAT THE CATHETER BALLOON WAS POSITIONED OUTSIDE OF THE BLADDER IN THE RETROPERITONEUM. THE IMAGING TEST FOUND DAMAGE TO THE BLADDER WALL, BUT NO DAMAGE TO THE RETROPERITONEAL. THE DOCTOR PLACED THE BALLOON BACK INTO THE BLADDER AND PT'S CONDITION WAS MONITORED FOR SEVERAL DAYS. ON (B)(6), THE CATHETER WAS REPLACED WITH A NEW ONE AND THE PT WAS DISCHARGED IN (B)(6).
N
Patient 1
THIS INVESTIGATION IS UNCONFIRMED, AS THE EVAL VERIFIED NO ABNORMALITIES OBSERVED ON THE RETURNED SAMPLE. THE CATHETER CAN BE INFLATED AND DEFLATED WITH NO DIFFICULTY. THE SHAFT THICKNESS WAS WITHIN SPEC. THE CATHETER WAS DISSECTED AND NO CONDITIONS WERE IDENTIFIED THAT WOULD CONTRIBUTE TO THE REPORTED PROBLEM. A REVIEW OF THE DEVICE LABELING IS ADEQUATE TO PREVENT THE REPORTED EVENT. THIS EVENT IS BEING REPORTED AS THE PM/510(K) AND THE PRODUCT CLASSIFICATION CODE REPRESENT A SIMILAR DEVICE WITH THE CATALOG NUMBER OF 016SS114. (B)(4).