It was reported that a patient underwent an ablation procedure with a thermocool smarttouch uni-directional navigation catheter and a deflection issue occurred during the procedure as the catheter could not deflect.The catheter was changed and the procedure was completed with no patient consequence.This event was originally assessed as not mdr reportable since the catheter is unable to deflect or relax completely; the user will not be able to use the device and will have to replace it.The most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.On august 22, 2016, the device was received in the biosense webster failure analysis lab and during visual inspection it was discovered that the peek housing is bent on the proximal side of ring #3 leaving the ring rough and the polyurethane margin is peeling.This finding has been assessed as mdr reportable because if electrodes of catheter are dented, squashed, lifted or the pu border is damaged, then there is potential risk to the patient such as vascular dissection.The exposed rough edge is the damage creating patient risk.
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(b)(4).It was reported that a patient underwent an ablation procedure with a thermocool smarttouch uni-directional navigation catheter and a deflection issue occurred during the procedure as the catheter could not deflect.The returned device was visually inspected upon receipt and the peek housing was found bent leaving the ring rough and the polyurethane margin peeling, which is why this complaint is mdr reportable.Further information received indicates that this condition was not observed during the procedure or prior to sending the catheter back.It may have happened while sending the catheter back to bwi.A scanning electron microscope (sem) test was performed and it was found that the body external surface presented evidence of scratching that might contributed to the bent condition.During manufacturing all the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent this type of damage/defect from leaving the facility.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.A deflection test was performed and the catheter passed even though the bent observed.The customer complaint cannot be confirmed.
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