BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053
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Catalog Number D133605IL |
Device Problems
Material Puncture/Hole (1504); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation details: the catheter was returned to biosense webster for evaluation.The evaluation has been completed.Bwi conducted a visual inspection and deflection evaluation of the returned catheter.Visual analysis of the returned sample revealed reddish material inside the pebax on the thermocool® smart touch¿ electrophysiology catheter deflection test was performed, in accordance with bwi procedures.The catheter passed deflection within specifications.Scanning electron microscope (sem) results show evidence of mechanical damage and a hole on the pebax surface.Object that caused the damage is unknown.No other anomalies were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The customer¿s reported deflection issue could not be confirmed as the as the catheter performed without any deflection issues.The evaluation determined that the cause of pebax damage failure cannot be established.Additionally, the customer had provided a photo of the complaint device to aid in the investigation.This investigation was performed based and determined that based only on the photo provided, the customer¿s complaint could not be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# pc-(b)(4).
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Event Description
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A patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab identified a hole in the pebax.It was initially reported by the customer that during the ablation procedure a deflection issue was encountered as the catheter was unable to deflect or relax completely.A second catheter was used to complete the operation.There was no patient consequence reported.The customer¿s reported deflection issue was assessed as not reportable since 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 2/26/2021, the bwi product analysis lab received the complaint device for evaluation.On 3/9/2021, the catheter was inspected and found with a reddish material inside the pebax.As such, on 3/10/2021 a scanning electron microscope (sem) analysis was done to identify if the integrity of the pebax was compromised.The sem results showed evidence of mechanical damage and a hole on the pebax surface.These findings were reviewed and determined the issue of a ¿hole¿ in the pebax is an mdr reportable malfunction since the integrity of the device was compromised.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through sem analysis on 3/10/2021 and reassessed t as mdr reportable.
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