Model Number D134805 |
Device Problems
Device Alarm System (1012); Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2021 |
Event Type
malfunction
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Event Description
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A patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.It was initially reported by the customer that during ablation an air bubble error occurred, so the thermocool® smart touch® sf bi-directional navigation catheter was removed and reverse blood flow into the catheter (where the spring coil is located) was confirmed.The catheter was exchanged and the action was completed.There were no patient consequences.The customer¿s reported issue of bubble error warning is not mdr reportable as the potential that it could cause or contribute to a death or serious injury, or other significant adverse event is low.The customer¿s reported blood flow into the pebax (where the spring coil is located) was assessed as not mdr reportable since there is no damage to the pebax integrity that could cause the foreign material travels into the blood circulation.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 27-aug-2021, the bwi product analysis lab received the complaint device for evaluation.On (b)(6) 2021, pal revealed that visual inspection of the device found a hole in the pebax with reddish material inside.This finding was reviewed and determined to be an mdr reportable malfunction since the integrity of the device has been compromised.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on (b)(6) 2021 and reassessed it as mdr reportable.
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Manufacturer Narrative
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Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection and irrigation evaluation of the returned device.Visual analysis of the returned sample revealed a hole with reddish-brown material in the pebax.The root cause of the pebax breakage cannot be established.All units are inspected prior leaving the facility to avoid these types of damages prior leaving the facility.Cool flow pump and pressure gage test were performed in accordance with bwi procedures.The device was working correctly, and no issues or bubble alarms were detected during the analysis.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 complaint regarding foreign material inside the pebax was confirmed.Regarding bubble error, no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.It should be noted that product failure is multifactorial.For product bubble error failure, the instructions for use contain the following recommendations: before use, check irrigation ports are patent by infusing heparinized normal saline through the catheter and tubing.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).(b)(4).
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Search Alerts/Recalls
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