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

Catalog Number D139505

Device Problems Image Orientation Incorrect (1305); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 15-feb-2024.The device evaluation was completed on 05-mar-2024.The qdot micro device was returned to biosense webster (bwi) for evaluation.A visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed reddish material and a hole in the pebax.The root cause of the hole in the pebax could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.A screening test was performed and the device was recognized correctly; however, hi force appeared due to an internal printed circuit board (pcb) issue.The blood found inside the pebax area may contribute to the force issue.A manufacturing record evaluation was performed and no internal actions was found during the review.The force issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: to ensure accurate force readings, verify that the force reading is near zero when the device is not in contact with tissue.If the force reading is not near zero when the device is not in contact with tissue, perform zeroing.If the force problem persists, replace the device cable or the device.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: material and/or chemical problem identified (c06) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as related to the customer¿s reported ¿force vector was inverted and inaccurate force readings¿ issues.-investigation findings: incompatible component/ accessory (c0402) / investigation conclusions: cause traced to component failure (d02) / component code: circuit board (g02005) were selected as related to the customer¿s reported ¿force vector was inverted and inaccurate force readings¿ issues.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a qdot micro catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.The force vector was inverted and there were inaccurate force readings on the carto 3 system.The caller re-zeroed the catheter but the issue persisted.The cable was new, so they did not replace the cable.When the catheter was replaced, the issue was resolved.No patient consequence reported.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 05-mar-2024, observed reddish material and a hole in the pebax.This event was originally considered non-reportable, however, bwi became aware of a hole in the pebax on 05-mar-2024 and have assessed this returned condition as reportable.

• Brand Name: QDOT MICRO
• 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: 18988421
• MDR Text Key: 338731264
• Report Number: 2029046-2024-01035
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• 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
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139505
• Device Lot Number: 31187938L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2023
• 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
• Treatment: UNK CABLE; UNK_CARTO 3