AMPLATZ ANCHOR¿

Additional Manufacturer Narrative

DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE DEVICE REVEALED THAT THE SUTURE WAS BROKEN, AND ITS PROXIMAL SECTION WAS RIPPED/TORN. NO OTHER ANOMALIES OR DAMAGES. A MANDREL OF 0.038 INCHES WAS INSERTED THROUGH THE CATHETER AND PASSED PROPERLY WITHOUT RESISTANCE UPON FUNCTIONAL TESTING. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED AND PATIENT EXPERIENCED PAIN. THE TARGET AREA WAS LOCATED IN THE BILIARY TRACT. AN AMPLATZ ANCHOR¿ WAS USED. UPON REMOVAL OF THE DRAIN FROM THE PATIENT'S BODY, THE END PART OF THE CATHETER BECAME STUCK AT THE STRING AND THE LOOP WAS NOT RELEASED. THE CATHETER WAS THEN FORCIBLY PULLED FROM THE PATIENT; CONSEQUENTLY, THE PATIENT EXPERIENCED PAIN. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

Additional Manufacturer Narrative

AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED AND PATIENT EXPERIENCED PAIN. THE TARGET AREA WAS LOCATED IN THE BILIARY TRACT. AN AMPLATZ ANCHOR WAS USED. UPON REMOVAL OF THE DRAIN FROM THE PATIENT'S BODY, THE END PART OF THE CATHETER BECAME STUCK AT THE STRING AND THE LOOP WAS NOT RELEASED. THE CATHETER WAS THEN FORCIBLY PULLED FROM THE PATIENT; CONSEQUENTLY, THE PATIENT EXPERIENCED PAIN. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED AND PATIENT EXPERIENCED PAIN. THE TARGET AREA WAS LOCATED IN THE BILIARY TRACT. AN AMPLATZ ANCHOR WAS USED. UPON REMOVAL OF THE DRAIN FROM THE PATIENT'S BODY, THE END PART OF THE CATHETER BECAME STUCK AT THE STRING AND THE LOOP WAS NOT RELEASED. THE CATHETER WAS THEN FORCIBLY PULLED FROM THE PATIENT; CONSEQUENTLY, THE PATIENT EXPERIENCED PAIN. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS STABLE.