BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM; INTRODUCER, CATHETER
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Model Number D138502 |
Device Problems
Break (1069); Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/24/2021 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent an atrial flutter ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium wherein the dilator and wire went through side irrigation hole of carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and damaged the tip of the sheath.It was reported that during the case, the sheath was initially used to perform right atrial flutter ablation in cavo-tricuspid isthmus line (cti).After cti, ablation catheter was retrieved to perform transeptal puncture with the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.While sheath was inside the patient, dilator with wire was inserted and advanced into the sheath to advance the entire system in superior vena cava (svc) and then retrieve wire to introduce the needle to perform transeptal puncture.After successfully and un-eventfully performing transeptal puncture and advancing the ablation catheter, slight difficulty was sensed by physician during manipulation of the sheath and catheter.Retrieval of both, unveiled that the side hole of the sheath was torn and tip of the sheath damaged.Assumption was that while inserting dilator with wire inside the sheath, wire went through the side hole as it was still at the tip of the dilator and not entirely out to shape a j at its tip.Therefore, since wire went through the side hole, then advancing the dilator over the wire though the side hole, damaged the tip of the sheath by tearing the side hole.No complications during or post-intervention were observed, and sheath tip appeared to not be missing any part; no fragments were generated.The surgery was delayed due to the reported event and the sheath was replaced.The procedure was successfully completed.No other medical intervention was required.There was no patient consequence.
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Manufacturer Narrative
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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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Manufacturer Narrative
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It was reported that a patient underwent an atrial flutter ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium wherein the dilator and wire went through side irrigation hole of carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and damaged the tip of the sheath.After successfully and un-eventfully performing transeptal puncture and advancing the ablation catheter, slight difficulty was sensed by physician during manipulation of the sheath and catheter.Retrieval of both, unveiled that the side hole of the sheath was torn and tip of the sheath damaged.Assumption was that while inserting dilator with wire inside the sheath, wire went through the side hole as it was still at the tip of the dilator and not entirely out to shape a j at its tip.Device evaluation details: on 21-feb-2022, the product was returned to biosense webster for evaluation.Bwi then conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample revealed that the irrigation hole was damaged, elongation was observed in the hole diameter.However, the tip was not found broken on the carto vizigo sheath.The irrigation hole was found damage, elongation was observed in the hole diameter.However, tip was not found broken.The root cause of the damage on the tip could be related to the dilator and wire insertion, the wire went through the side hole damaging the tip area.The lot number of the device was verified during the evaluation process as 00001665.As such, a device history record evaluation was performed, and no internal actions related to the reported complaint condition were identified.Additionally, based on the verified lot number, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date (26-may-2022) and h4.Device manufacture date (26-may-2021) have been populated.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the broken tip.Investigation findings: mechanical problems identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the issue of the dilator going through the irrigation hole in the device.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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