BIOSENSE WEBSTER INC NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING
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Catalog Number NS7TCDL174HS |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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E 1.Initial reporter phone : (b)(6) if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.Manufacturer's reference number: (b)(4).
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Event Description
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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure which included a navistar¿ electrophysiology catheter and when the nurse took the catheter out of the box, the packaging was already open and clearly not sterile anymore.The packaging is not available for return as it was discarded.There was no adverse patient consequence.
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Manufacturer Narrative
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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure which included a navistar¿ electrophysiology catheter and when the nurse took the catheter out of the box, the packaging was already open and clearly not sterile anymore.The packaging is not available for return as it was discarded.There was no adverse patient consequence.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection of the returned device was performed in accordance with bwi procedures.Visual analysis of the returned device revealed that no damage or anomalies were observed on the device.The original packaging was not returned; therefore, further investigation could not be performed.The open pouch issue was confirmed based on the provided pictures by the customer.A manufacturing record evaluation was performed for the finished device 31004952m, and no internal action was found during the review.The issue reported by the customer was confirmed.The potential cause cannot be determined.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Manufacturer Narrative
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On 22-apr-2024, the product investigation details were updated to include potential cause and reference to instruction for use (ifu).Below is the updated product investigation: it was reported that a patient underwent an atrial fibrillation (afib) ablation procedure which included a navistar¿ electrophysiology catheter and when the nurse took the catheter out of the box, the packaging was already open and clearly not sterile anymore.The packaging is not available for return as it was discarded.There was no adverse patient consequence.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection of the returned device was performed in accordance with bwi procedures.Visual analysis of the returned device revealed that no damage or anomalies were observed on the device.The original packaging was not returned; therefore, further investigation could not be performed.The open pouch issue was confirmed based on the provided pictures by the customer.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.The issue reported by the customer was confirmed based on the pictures received from the customer.The potential cause cannot be conclusively determined.It could be related to the handling of the device after the device left the manufacturing facilities, probably during the transport or storage of the device.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points to avoid this type of damage from leaving the facility.The instruction for use contains the following precautions: the sterile packaging and catheter should be inspected prior to use.If the packaging is received in the future, the product analysis will be performed.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Search Alerts/Recalls
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