MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSOSTAR¿ NAV CIRCULAR MAPPING CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D140401

Device Problems Device-Device Incompatibility (2919); Material Protrusion/Extrusion (2979); Material Twisted/Bent (2981)

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

Event Date 03/21/2023

Event Type  malfunction  

Manufacturer Narrative

E1 initial reporter phone: (b)(6).The bwi product analysis lab received a photo of the complaint device for evaluation.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.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an unspecified ablation procedure involving a lassostar¿ nav circular mapping catheter and the device was difficult to maneuver.When the lassostar was removed, there was a visible kink on the device.No fragments were generated.The device was replaced and the procedure was successfully completed without any delays.No patient consequences were reported.Additional device details: the damage resulted in an exposed wire.There were no sharp or lifted rings; however, the plastic between the electrodes was shrugged.Resistance was also noted: it was not possible to pass through the heliostar balloon when the inflation knob was on the ¿deflated mode¿.Then the inflation knob retracted to ¿inflate mode¿ to allow the catheter to pass and then extended again to ¿deflate mode¿ and functional until later in the procedure where abundant resistance to move occurred.At this point, the device was withdrawn from the patient.Bent shaft is not mdr-reportable.Resistance with lumen is not mdr-reportable.Internal components exposed is mdr-reportable.

Manufacturer Narrative

On 27-apr-2023, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an unspecified ablation procedure involving a lassostar¿ nav circular mapping catheter and the device was difficult to maneuver.When the lassostar was removed, there was a visible kink on the device.No fragments were generated.The device was replaced and the procedure was successfully completed without any delays.No patient consequences were reported.Device evaluation details: visual analysis of the returned sample revealed bent marks on the shaft.No other anomalies or damage were observed on the device.A dimensional test was performed, and the outer diameters of the device were found within the specifications.The failure observed could be related to the excessive force applied during the manipulation of the device; however, this can not be conclusively determined.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer was confirmed since it was observed bent marks on the shaft.It should be noted that product failure is multifactorial.The instructions for use contain the following recommendations: if a lassostar¿ catheter is used with the heliostar¿ catheter, do not extend the heliostar¿ catheter beyond the sheath tip until the lassostar¿ catheter has been fully advanced out of the guidewire lumen.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: LASSOSTAR¿ NAV CIRCULAR MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• 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: 16782695
• MDR Text Key: 313710553
• Report Number: 2029046-2023-00864
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835020335
• UDI-Public: 10846835020335
• Combination Product (y/n): N
• PMA/PMN Number: K211219
• 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,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2023
• Device Model Number: D140401
• Device Catalogue Number: D140401
• Device Lot Number: 30835477L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2022
• 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: HELIOS GUIDESTAR 13.5 FR BY BW