BIOSENSE WEBSTER INC QDOT MICRO; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Catalog Number D139402 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/31/2023 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with two qdot micro catheters for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax with internal parts exposed on both devices.Initially it was reported that after the left pulmonary veins had already been blocked and the right veins were to be started, massive increases in contact force suddenly occurred during energy delivery.The catheter tip was inspected.The tip showed an entry of blood.Therefore, the catheter was replaced.The second catheter then had the same problem.Only the use of a third catheter could solve the problems.The procedure was successfully completed without any consequences for the patient.Surgery was delayed 30 minutes.Additional information was received.No difficulty experienced while maneuvering the catheter or during the withdrawal.Unknown if the catheter pebax or if any other part of the tip was physically damaged.Clarification received was that there were 4 qdot micro catheters with this same issue.The biosense webster, inc.Product analysis lab received the two devices for evaluation and per the evaluation completions on (b)(6) 2024, revealed reddish brown material inside and a hole on the pebax with internal parts exposed on both devices.This event was originally considered non-reportable, however, bwi became aware of the hole on the pebax with internal parts exposed on both devices on (b)(6) 2024 and have assessed these returned conditions as reportable.
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Manufacturer Narrative
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The bwi product analysis lab received the device for evaluation on 08-feb-2024.The device evaluation was completed on 29-feb-2024.The device was returned for evaluation.The returned device's visual inspection and screening test were performed following biosense webster (bwi) procedures.Visual analysis of the returned device revealed reddish brown material inside and a hole on the pebax with internal parts exposed; however, the hole could be related to the handling after the procedure but, it cannot be conclusively determined.The device was connected to the carto 3 system and it was recognized; however, error 105 was displayed on the screen due to an open circuit in the tip area.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the complaint were found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The reddish material on the pebax could be related to the force issue, therefore, the complaint was confirmed.It should be noted that product failure is multifactorial.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.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: unintended use error caused or contributed to event (d1102)) / component code: sleeve (b(6) were selected as related to the customer¿s reported ¿force issue¿ and the ¿tip showed an entry of blood¿ issue.In addition, the biosense webster inc.Analysis finding of the ¿reddish brown material inside and a hole on the pebax with internal parts exposed¿.Investigation findings: open circuit (b) (6)) / investigation conclusions: cause not established (d15) / component code: sensor (b)(6) )were selected as related to the customer¿s reported ¿force issue¿ and the ¿tip showed an entry of blood¿ issue.In addition, the biosense webster inc.Analysis finding of the open circuit in the tip area.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr# for product code d139402 (qdot micro) (2) mfr # 2029046-2024-00890 for product code d139402 (qdot micro).
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