MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT-MICRO, UNI-DIRECTIONAL, D CURVE, C3, SPLIT HANDLE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number D139401

Device Problems Signal Artifact/Noise (1036); Material Puncture/Hole (1504)

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

Event Date 07/07/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unspecified ablation procedure with a qdot-micro, uni-directional, d curve, c3, split handle and post procedure the bwi product analysis lab identified a hole in the pebax.During the procedure, noise was detected on intracardial signals (map port 1-2) of the qdot catheter.After replacing of the appropriate catheter cable the problem with this catheter was not solved.This catheter was replaced with another one and from the same type, so that procedure was ended successfully.So there was no damage and consequences caused to the patient.The noise issue is not mdr-reportable.The hole in the pebax is mdr-reportable.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).The photo analysis and product investigation were completed.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, on the printing of the cardiolab screen was observed a signal noise.Additionally, the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and functional test of the returned device.Visual inspection was performed, and a hole was observed on the pebax surface with reddish material inside.The root cause of the damage on pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specifications and procedures.However, it could be related to the handling of the device during the procedure, but this cannot be conclusively determined.An electrical test was performed, and no electrical issues were found.The blood inside the pebax could be related to the electrical issue reported by the customer.The customer complaint was confirmed.A manufacturing record evaluation was performed for the finished device batch number 31049025l, and no internal actions were identified.As part of biosense webster's 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 reference number: (b)(4).

• Brand Name: QDOT-MICRO, UNI-DIRECTIONAL, D CURVE, C3, SPLIT HANDLE
• 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: 18048287
• MDR Text Key: 327628838
• Report Number: 2029046-2023-02484
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835017045
• UDI-Public: 10846835017045
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139401
• Device Lot Number: 31049025L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1