BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM; INTRODUCER, CATHETER
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Model Number D138502 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/06/2022 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a broken tip issue was encountered.When this product was attempted to be inserted into the patient¿s body and used, it could not be inserted into the patient¿s body, physician visually confirmed that the tip was slightly cracked.It is unclear if this was the procedure from the beginning.The issue was resolved by changing this product to another one.After that procedure was ended normally.The procedure was completed without patient's consequence.There was no patient consequence.
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a broken tip issue was encountered.When this product was attempted to be inserted into the patient¿s body and used, it could not be inserted into the patient¿s body, physician visually confirmed that the tip was slightly cracked.On 1-aug-2022, additional information was received indicating that the damage was like a ¿dent¿.The carto vizigo¿ 8.5f bi-directional guiding sheath - medium was not buckled or rolled up on itself.It was not split.No internal sheath mechanisms were exposed.The tip was not rough/non-slippery.There was no lifted or damage electrode.Device investigation details: on 1-aug-2022, a picture was received for the customer to aid in the evaluation and the evaluation was completed following biosense webster's procedures.According to the picture received, the tip of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was observed slightly cracked, however, at this time it is not possible to determine the root cause of the cracked condition noted on the tip.A device history record was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed based on the picture received.The device has not been returned for analysis and cannot be assigned a root cause based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Note: h6.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.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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On 31-aug-2022, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a broken tip issue was encountered.When this product was attempted to be inserted into the patient¿s body and used, it could not be inserted into the patient¿s body, physician visually confirmed that the tip was slightly cracked.It is unclear if this was the procedure from the beginning.The issue was resolved by changing this product to another one.After that procedure was ended normally.The procedure was completed without patient's consequence.There was no patient consequence.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual analysis of the returned sample revealed that the tip was observed slightly bent/dent with no broken, exposed, or missing parts, and stress marks were observed; this damage could be related to the customer's complaint.The damage could be related to the handling of the device during the procedure since stress marks were observed.However, this cannot be conclusively determined.A device history record was performed, and no internal action related to the reported complaint were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.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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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) on 28-oct-2022, it was noticed the h6.Investigation conclusions code of "cause not established (d15)" was inadvertently omitted from the 3500a supplemental mdr # 3.As such, the field has now been populated.
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