Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed that the pebax area had a tear and reddish material.No other damage was observed.The device was connected to carto 3 system, and the device was recognized correctly; however, errors 105 and 106 appeared on the system due to an open circuit in the tip area.A manufacturing record evaluation was performed for the finished device, and no internal action related to the reported complaint condition were identified.The issue reported by the customer was confirmed.This could be related to the sensor and the reddish material observed.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: material and or chemical problem identified (c06) investigation conclusions: unintended use error caused or contributed to event (d1102) component code: sleeve (g04115) were selected as related to the tear in the pebax.Investigation findings: open circuit (c0205) investigation conclusions: cause not established (d15) component code: sensor (g03012) were selected as related to the customer's reported contact force issue.E1: initial reporter phone: (b)(6).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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It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified the pebax area was torn and a reddish material was also observed.It was initially reported by the customer that while ablating for the left pulmonary vein (lpv) an unusual contact force (cf) increased occurred.The physician pointed out that the cf could become over 50 once flowed so the catheter might not be right.However, the error and the interference mark would not appear.The cf unusually could increase once started ablating.Therefore, they replaced the thermocool® smart touch® sf bi-directional navigation catheter and the catheter issue resolved.The procedure was completed without patient's consequence.The customer¿s reported contact force issue is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 19-jan-2024, the bwi pal revealed that a visual inspection of the returned device found the pebax area was torn and a reddish material was also observed.These findings were reviewed and determined the issue of a ¿tear¿ on the pebax is an mdr reportable malfunction since the integrity of the device has been compromised.
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