inforMED
MalfunctionFEN

BALLOON CATHETER RUSCH 100% SILICONE

Received Dec 23, 2019 · Event occurred Nov 6, 2019

Report 8040412-2019-00376 · MDR key 9512798

Device

Generic name

Balloon Catheter

Catalog number

MEDICAL UNKNOWN

Lot number

UNKN

Product problems

  • Deflation Problem
  • Deflation Problem

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

(B)(4). REPORT 8040412-2019-00376 DEVICE IDENTIFICATION HAS BEEN UPDATED AS BALLOON CATHETER RUSCH 100% SILICONE. HOWEVER, THE CATALOG NUMBER REMAINS UNKNOWN. ONE PIECE OF THE ACTUAL SAMPLE WAS RETURNED FOR INVESTIGATION. BASED ON THE COMPLAINT DESCRIPTION IT WAS REPORTED THAT THE BALLOON COULD NOT BE DEFLATED. FURTHER INVESTIGATION WAS CONDUCTED BY INFLATING THE SAMPLE WITH 10ML OF WATER. IT WAS NOTICED THAT THE BALLOON WAS ASYMMETRY AND THE BALLOON RATIO DID NOT MEET THE ACCEPTABLE LIMIT FOR BALLOON ASYMMETRY. THE SAMPLE WAS THEN SUBJECTED TO DEFLATION TEST USING AN EMPTY SYRINGE WITHOUT PLUNGER. HOWEVER, IT WAS FOUND THAT THE BALLOON COULD NOT BE FULLY DEFLATED AS EXPERIENCED BY THE COMPLAINANT. NON DEFLATION MIGHT BE DUE TO THE ASYMMETRICAL CONDITION OF THE BALLOON WHICH RESULTED IN OCCLUSION OF THE INFLATION LUMEN EYE DURING DEFLATION PROCESS. OTHER REMARKS: BASED ON EXPERIENCE, BALLOON ASYMMETRY COULD HAPPEN DUE TO UNEVEN BALLOON WALL THICKNESS, OR UNEVEN BONDING LENGTH. FURTHER INVESTIGATION AND CORRECTIVE ACTION WILL BE ADDRESSED THROUGH AN NC. IN CONCLUSION, AFTER INVESTIGATION, IT WAS NOTICED THAT THE BALLOON WAS ASYMMETRY WHERE THE BALLOON RATIO DID NOT MEET THE ACCEPTABLE LIMIT FOR BALLOON ASYMMETRY. DURING DEFLATION TEST, IT WAS FOUND THAT THE BALLOON COULD NOT BE FULLY DEFLATED AS EXPERIENCED BY THE COMPLAINANT. NON DEFLATION MIGHT BE DUE TO THE ASYMMETRICAL CONDITION OF THE BALLOON WHICH RESULTED IN OCCLUSION OF THE INFLATION LUMEN EYE DURING DEFLATION PROCESS.

Additional Manufacturer Narrative

(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

Description of Event or Problem

IT WAS REPORTED THAT THE BALLOON COULD NOT BE DEFLATED. THE DEVICE WAS REMOVED WITH THE BALLOON INFLATED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.