[175183689]
Internal reference: (b)(4). This case was reviewed and investigated according to the manufacturer? S policy. Additional information obtained indicates the physician was attempting to cross a non-tortuous cto at the posterior tibial artery. When removing the manufacturers device resistance with the guidewire (another manufacturer''s device) was experienced. The manufacturer's device and the guidewire became stuck and were removed together as a system. No medical or surgical intervention was performed to remove the devices. All portions of the manufacturer's device were accounted for upon removal. Under fluoroscopy a portion of a device was observed to remain in the patient. It was initially thought to be a portion of the manufacturer's device and later determined to be the guidewire (another manufacturer's device). Per device analysis all portions of the manufacturer's device were intact and accounted for, the device was not missing any material. The probable cause of the reported? Tip of the catheter broke off inside the patient? Could not be confirmed as no missing pieces were observed. The probable cause of the secondary issue (wire resistance) is use of a hydrophilic guidewire with the manufacturer's device, which is contraindicated. The manufacture's quick reference guide states in the system setup to use? 0. 014? Nonhydrophilic guidewires with long-coil transition.? Additionally, the quick reference guide warns:? Needle wire must be nonhydrophilic with long-coil transition.? No information available. The implant or explant dates are not applicable to this device. Not applicable for this device. The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
Patient Sequence No: 1, Text Type: N, H10
[175183690]
It was reported during a therapeutic peripheral procedure, on the second attempt to re-enter the peripheral vessel the tip of the manufactures device dislodged inside the patient. The tip is in a location that is not moving and the patient is in no danger, the tip is being left in the vessel. Further information provided it was not a portion of the manufacturer's device that separated but another manufacturer's device and remains in situ. This report is being submitted because an adverse event of separation of another manufacturer's guidewire device occurred while the manufacture's device was in use.
Patient Sequence No: 1, Text Type: D, B5