SHUNT PAK, 11.5FR DOUBLE-VALVE
Received Jun 6, 2024 · Event occurred Apr 8, 2024
Report 1625685-2024-00059 · MDR key 19476782
Device
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A0401. PATIENT PROBLEM CODE: F1903.
Description of Event or Problem
THIS IS A COMPLAINT ABOUT DENVER SHUNT VENOUS CATHETER FRACTURED. PLACEMENT DATE: (B)(6) 2015. DATE OF TEAR CONFIRMATION: (B)(6) 2024. APPROACH SITE: RIGHT SUBCLAVIAN VEIN. CIRCUMSTANCES OF DISCOVERY: DISCOVERED DURING CT INVESTIGATE FOR SUSPECTED RECURRENCE OF HEPATOCELLULAR CARCINOMA. IT WAS REPORTED THAT THE TIP END POINT OF THE CATHETER FRACTURED HAD REACHED THE RIGHT VENTRICLE, BUT WAS REMOVED PERCUTANEOUSLY. NO DAMAGE TO THE PATIENT'S HEALTH. THE ORIGINAL CATHETER HAS BEEN DISCARDED AND IS NOT RECOVERABLE.
Additional Manufacturer Narrative
PR (B)(4) FOLLOW-UP EMDR FOR DEVICE EVALUATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. SHOULD YOU EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT, EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE.
Description of Event or Problem
THIS IS A COMPLAINT ABOUT DENVER SHUNT VENOUS CATHETER FRACTURED. PLACEMENT DATE: (B)(6) 2015. DATE OF TEAR CONFIRMATION: (B)(6) 2024. APPROACH SITE: RIGHT SUBCLAVIAN VEIN. CIRCUMSTANCES OF DISCOVERY: DISCOVERED DURING CT INVESTIGATE FOR SUSPECTED RECURRENCE OF HEPATOCELLULAR CARCINOMA. IT WAS REPORTED THAT THE TIP END POINT OF THE CATHETER FRACTURED HAD REACHED THE RIGHT VENTRICLE, BUT WAS REMOVED PERCUTANEOUSLY. NO DAMAGE TO THE PATIENT'S HEALTH. THE ORIGINAL CATHETER HAS BEEN DISCARDED AND IS NOT RECOVERABLE. DID THE SHUNT REQUIRE REPLACEMENT DUE TO THIS EVENT? NO REPLACEMENT OF SHUNT REQUIRED, ONLY REMOVAL. LOT NUMBER ASSOCIATED WITH REPORTED ISSUE. UNKNOWN.