TAUT INTRADUCERS 10/BX7.5 FR X 3.5

Additional Manufacturer Narrative

(B)(4). MEDWATCH REPORT NUMBER MW5070911. THE DEVICE HISTORY REVIEW FOR THE PRODUCT TAUT INTRODUCERS 10/BX7.5 FR X 3.5, LOT #73K1600792 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

Description of Event or Problem

THE RUBBER SEAL FROM TAUT INTRODUCER DISLODGED DURING INSERTION OF TAUT CATHETER AND PUSHED INTO THE ABDOMEN. IT WAS NOTICED IMMEDIATELY BY THE SURGEON AND RETRIEVED FROM THE ABDOMEN WITH A GRASPER. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER RETURNED ONE UNIT PI-93 TAUT INTRADUCERS 10/BX 7.5 FR X 3.5 FOR INVESTIGATION. THE CLEAR DISC THAT IS SUPPOSED TO BE INSIDE OF THE CHECK VALVE WAS RETURNED LOOSE. THE DISC MOST LIKELY FELL OUT OF THE CHECK VALVE DUE TO THE CATHETER GETTING STUCK ON IT AND PULLING IT OUT. IT COULD NOT BE DETERMINED WHY THE CATHETER GOT STUCK ON THE CLEAR DISC. THE CATHETER THAT WAS USED WAS NOT RETURNED. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. THE IFU FOR THIS PRODUCT, L03610, WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE IFU STATES, "INSERT THE INTRADUCER ASSEMBLY THROUGH THE ABDOMINAL WALL USING A CONTINUOUS, CONTROLLED, SLOW, FORWARD MOTION. UNDER DIRECT VISUALIZATION USING THE LAPAROSCOPE, PENETRATE THE PERITONEUM UNTIL THE CATHETER TIP IS JUST VISIBLE WITHIN THE PERITONEAL CAVITY." "IMMEDIATELY UPON ENTRY INTO THE PERITONEAL CAVITY, HOLD THE INTRADUCER IN PLACE AND WITHDRAW THE NEEDLE COMPLETELY. REMOVE CHECK VALVE FROM NEEDLE HUB AND REINSTALL ON INTRADUCER CATHETER HUB." THE REPORTED COMPLAINT OF "FELL APART DURING USE" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. THE CLEAR DISC FROM THE CHECK VALVE WAS RETURNED LOOSE. OTHER REMARKS: NO OTHER PROBLEMS WERE FOUND WITH THE DEVICE. IT APPEARS THAT THE CLEAR DISC MOST LIKELY FELL OUT OF THE CHECK VALVE DUE TO THE CATHETER GETTING STUCK ON THE DISC AND PULLING IT OUT. HOWEVER, IT COULD NOT BE DETERMINED WHY THE CATHETER WOULD GET STUCK ON THE DISC. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE DEVICE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. IT CANNOT BE DETERMINED WHAT CAUSED THE REPORTED COMPLAINT ISSUE. NO FURTHER ACTION WILL BE TAKEN.

Description of Event or Problem

THE RUBBER SEAL FROM TAUT INTRODUCER DISLODGED DURING INSERTION OF TAUT CATHETER AND PUSHED INTO THE ABDOMEN. IT WAS NOTICED IMMEDIATELY BY THE SURGEON AND RETRIEVED FROM THE ABDOMEN WITH A GRASPER. THERE WAS NO PATIENT INJURY.