BIOSENSE WEBSTER INC QDOT MICRO; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Catalog Number D139504 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/08/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1.Initial reporter phone: (b)(6).The bwi product analysis lab received the device for evaluation on (b)(6) 2024.The device evaluation was completed on (b)(6) 2024.The product was returned for evaluation.Biosense webster (bwi) conducted a visual inspection and screening test of the returned device.Visual analysis of the returned device revealed reddish brown material inside and a hole on the pebax with internal parts exposed.The magnetic and force feature was tested, and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.The force issue described was unable to be duplicated during the product investigation; however, the blood inside the pebax area found could be related to the reported issue as a potential cause.The root cause of the damage could be related to the usage of the device during procedure; however, this cannot be conclusively determined.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.A manufacturing record evaluation was performed for the finished device and no internal actions related to the reported complaint condition were identified.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
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Event Description
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It was reported that a patient underwent a persistent atrial fibrillation procedure with a qdot micro for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax with internal parts exposed.Initially it was reported that during the procedure during ablation, abnormal contact force occurred.Catheter unplugged and replugged and problem was unsolved.They changed the cable and the problem was also unsolved.They changed the catheter to a new qdot catheter and the problem resolved.The procedure was successfully completed.No clinical consequence for the patient.Lengthening of procedural time was approximately 5 minutes.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2024, there was reddish brown material inside and a hole on the pebax with internal parts exposed.This event was originally considered non-reportable, however, bwi became aware of a hole on the pebax with internal parts exposed on (b)(6) 2024 and have assessed this returned condition as reportable.
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Search Alerts/Recalls
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