Model Number 10604 |
Device Problem
Contamination (1120)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 10/30/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device is a combination product.
|
|
Event Description
|
It was reported that device contamination occurred.A 3.00x24mm synergy stent was used in a procedure.However, the stent was contaminated.No patient complications were reported and the patient's status was stable.
|
|
Event Description
|
It was reported that device contamination occurred.A 3.00x24mm synergy stent was used in a procedure.However, the stent was contaminated.No patient complications were reported and the patient's status was stable.
|
|
Manufacturer Narrative
|
Device is a combination product.Device evaluated by mfr.:synergy ii us mr 3.00 x 24 mm stent delivery system was returned for analysis in a biohazard bag, without product mandrel & stent protector and with the proximal region of the hypotube shaft including the manifold missing.A visual examination of the stent found signs of stent damage.Stent struts in mid to distal stent region were noted to be lifted and pulled over the distal balloon cone.The undamaged stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed signs of damage on the distal end of the bumper tip.A visual and tactile examination of the hypotube shaft found the shaft broken at 50.4 cm proximal to the distal end of the tip as well as a shaft kink situated at 47.2 cm proximal to the distal end of the tip.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.D10: returned to manufacturer date corrected from 22nov2019 to 05dec2019.
|
|
Search Alerts/Recalls
|