Model Number PE074F5 |
Device Problem
Pacing Problem (1439)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/21/2015 |
Event Type
malfunction
|
Manufacturer Narrative
|
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.A device history record review was completed and documented that device met all specifications upon distribution.
|
|
Event Description
|
It was reported that it was unable to pace after the catheter was connected to an external pacemaker during use.The catheter was replaced and the problem was solved.Further details could not be obtained.There were no patient complications reported.
|
|
Manufacturer Narrative
|
One bipolar pacing catheter with attached terumo 2 ml syringe was returned for evaluation.Continuity testing confirmed a full open condition of the distal circuit.The proximal circuit was found to be continuous.A cut down of the catheter body was performed just proximal of the proximal electrode to expose the pacing leadwires.The distal leadwire was found to be broken around the solder joint.No visible damage to the balloon, windings, and catheter body was observed.The balloon inflated clear and concentric with 1.3 cc air and remained inflated for 5 min without leakage.Balloon inflation test was performed using lab syringe with 1.3 cc air by holding the balloon under water.Visual examinations were performed under microscope at 20x magnification and with the unaided eyes.The customer report of pacing issue was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.
|
|
Search Alerts/Recalls
|