MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT MICRO¿ CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number D139504

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a qdot micro¿ catheter.At the end of the procedure, the physician had noticed that the qdot catheter had blood residue inside the lumen, at the tip of the catheter.No adverse patient consequence was reported.Additional information received indicated that the tip looked a little damaged.There was no biological material found, just blood at the tip.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.

Manufacturer Narrative

The product has not returned for analysis, however, a picture was provided by the customer.Evaluation is still in progress.The 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.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).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a qdot micro¿ catheter.At the end of the procedure, the physician had noticed that the qdot catheter had blood residue inside the lumen, at the tip of the catheter.No adverse patient consequence was reported.Additional information received indicated that the tip looked a little damaged.There was no biological material found, just blood at the tip.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to the picture provided, a reddish material (presumably blood) was observed inside the pebax; however, no external damages were observed on the device.The customer complaint was confirmed based on the picture received.The device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual analysis revealed reddish material and a hole in the surface of the pebax.A manufacturing record evaluation was performed for the finished device 31210015l number, and no internal actions related to the reported complaint condition were identified.Additionally, the manufacture and expiration dates have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.The customer complaint was confirmed.The root cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.The instructions for use contain the following recommendations: when cleaning the tip electrode, be careful not to twist the tip electrode with respect to the catheter shaft; twisting may damage the tip electrode bond and loosen the tip electrode or may damage the contact force sensor.In addition, in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.After insertion, slide the insertion tube back toward the handle.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.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 reference number: (b)(4).

• Brand Name: QDOT MICRO¿ CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18862461
• MDR Text Key: 337558216
• Report Number: 2029046-2024-00774
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016741
• UDI-Public: 10846835016741
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139504
• Device Lot Number: 31210015L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 8.5F SHEATH WITH CURVE VIZ MDC