RELIEVA INSPIRA AIR 18X40MM BALLOON CATHETER
Received Sep 30, 2011 · Event occurred Sep 1, 2011
Report 3005172759-2011-00009 · MDR key 2278784
Device
Product problems
- Deflation Problem
- Material Separation
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ACCLARENT WAS MADE AWARE OF AN EVENT ON (B)(6) 2011, FOR AN EVENT INVOLVING AN 18X40MM INSPIRA AIR DEVICE NOTED TO HAVE DIFFICULTY DEFLATING. NO PT INJURY WAS APPLICABLE. THE DEVICE WAS RETURNED TO ACCLARENT FOR EVALUATION ON (B)(6) 2011. FOLLOW UP WITH THE ACTING PHYSICIAN WAS PERFORMED ON (B)(6) 2011. THE DEVICE WAS NOTED TO HAVE BEEN PULLED WITH FORCE UPON TWO INFLATIONS TO CREATE STABILIZATION OF THE BALLOON POSITION. UPON THE THIRD INFLATION, STRETCHING OF THE SHAFT OCCURRED FROM EXCESSIVE FORCE, RESULTING IN DEFLATION DIFFICULTY AND SEPARATION OF THE BALLOON CATHETER. THE REMAINING PORTION WAS GRASPED WITH CUP AND ALLIGATOR FORCEPS AND WAS ABLE TO BE REMOVED PROVIDING A SAFE AIRWAY. THE PT DID WELL WITH NO SEQUELAE.
Additional Manufacturer Narrative
DEVICE EVALUATION CONFIRMED THAT THE DEVICE WAS STRETCHED TO THE POINT OF SEPARATION. NO MISSING PARTS OF THE BALLOON CATHETER WERE NOTED. BASED ON THE INFO PROVIDED, ACCLARENT BELIEVES THE INSPIRA AIR DEVICE PERFORMED AS INTENDED IN THE FIRST AND SECOND DILATIONS. THE EXCESSIVE TENSION USED TO MAINTAIN THE BALLOON POSITION IN THE THIRD DILATION IS SUSPECTED TO HAVE STRETCHED THE BALLOON SHAFT, EVENTUALLY DISRUPTING THE BALLOON'S ABILITY TO PROPERLY DEFLATE. A MANUFACTURING REVIEW WAS CONDUCTING AND NO ABNORMALITIES WERE NOTED. NO NEGATIVE TRENDS WERE IDENTIFIED FROM A REVIEW OF THE COMPLAINT DATABASE. ACCLARENT'S IFU'S WARNINGS AND PRECAUTIONS STATES TO NEVER ADVANCE OR RETRACT THE DEVICES AGAINST RESISTANCE AS THIS COULD CAUSE DEVICE DAMAGE. ACCLARENT WILL CONTINUE TO UPDATE THE FILE WITH ANY ADDITIONAL INFO AND PROVIDE SUBSEQUENT REPORTS IF REQUIRED.