PRUITT IRRIGATION OCCLUSION CATHETER
Received Apr 14, 2023 · Event occurred Mar 15, 2023
Report 1220948-2023-00053 · MDR key 16742964
Device
Generic name
Occlusion Catheter
Manufacturer
Lemaitre Vascular, Inc.Model number
2102-09Catalog number
2102-09
Lot number
QPI1056
Product problems
- Failure to Deflate
- Failure to Deflate
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PRUITT IRRIGATION OCCLUSION CATHETER BALLOON FAILED TO DEFLATE DURING THE PRE-USE CHECK. THE DEVICE WAS NOT USED FOR THE PROCEDURE.
Additional Manufacturer Narrative
THE PRODUCT WAS RECEIVED FOR EVALUATION AND THE REPORTED ISSUE WAS CONFIRMED. WHEN THE BALLOON WAS INFLATED THE BALLOON FAILED TO DEFLATE. THE BALLOON WAS REMOVED FROM THE DEVICE AND THE SKIVE HOLE WAS INSPECTED. THE SKIVE HOLE WAS NOT COMPLETELY CUT AND THE CUT MATERIAL WAS NOT REMOVED FROM THE CATHETER LUMEN. AS A RESULT, THE MATERIAL REMAINED COVERING THE SKIVE HOLE. THIS ALLOWED FLUID TO FILL THE BALLOON, BUT CREATED A BLOCKAGE AND PREVENTED THE BALLOON FROM DEFLATING. THIS ISSUE IS DUE TO A MANUFACTURING ERROR. THE LOT HISTORY RECORD FOR THE DEVICE WAS REVIEWED, NO ISSUES WERE FOUND DURING MANUFACTURING OR PACKAGING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. ADDITIONALLY, WE HAVE NOT RECEIVED ANY REPORTS OF SIMILAR ISSUES OCCURRING FOR THIS LOT.