Device evaluation details: the device evaluation has been completed.The device was inspected, and it was found with splines and some rings bent and lifted; however, polyurethane (pu) around of the bent rings was observed.This issue could be related with the handling of the device during the procedure since in the manufacturing process there are control inspection points to avoid this kind of issues.A manufacturing record evaluation was performed for the finished device, and no internal action related to the reported complaint condition were identified.The customer complaint was confirmed.The root cause of the damage on electrodes could be related with the handling during the procedure.The instructions for use (ifu) states that do not use pentaray¿ catheters in patients with prosthetic valves.A relative contraindication for cardiac catheter procedures is active systemic infection.Unit was inspected prior leaving the facility as there are functional tests and inspections at control points based on the process.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).
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A patient underwent an ablation procedure with a pentaray nav high-density mapping eco catheter for which biosense webster¿s product analysis lab identified electrode rings on the returned complaint device are bent and lifted.It was initially reported by the customer that the pentaray nav high-density mapping eco catheter became entangled in the mechanical valve of the patient.The catheter was able to be extracted without injury to the patient or the valve.Catheter was removed intact; the procedure completed.There were no patient consequences.Additional information received indicated there was no difficulty was experienced while maneuvering the catheter during the procedure.There was some resistance when trying to withdraw it from the mechanical valve but once it was released, the catheter was withdrawn successfully.The customer did not report any sharp edges, no detachments, and the tip was not knotted and no medical or surgical intervention was not required to release the device.A argon 8.5 french sheath was used during the procedure.With the information available, the initial event was reported as not reportable since the device was removed without surgical intervention, or without using a different device, the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 10/9/2020, the bwi product analysis lab received the complaint device for evaluation.On 11/11/2020, during product evaluation it was found electrode rings were damaged as they were found bent and lifted.These findings are considered to be mdr reportable malfunctions.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through product analysis on 11/11/2020 and reassessed it as mdr reportable.
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