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

Catalog Number D140401

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

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

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Biosense webster manufacturer's reference number (b)(4) has 2 reports.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 with a lassostar¿ nav circular mapping catheter and due to resistance 4 lassostars were either physically damaged or provided an error 116 force sensor error.It was confirmed that two of the lassostars had a kinked shaft and broken sensor.No patient consequences were reported.No further procedural details were provided.The kinked shaft is not mdr-reportable.The (physically) broken sensor is mdr-reportable.

Manufacturer Narrative

On 28-aug-2023, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.The photo analysis of received photos was completed as well.It was reported that a patient underwent an unspecified ablation procedure with a lassostar¿ nav circular mapping catheter and due to resistance 4 lassostars were either physically damaged or provided an error 116 force sensor error.It was confirmed that two of the lassostars had a kinked shaft and broken sensor.No patient consequences were reported.No further procedural details were provided.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the tip was with a broken and twisted condition, exposed wires were observed, these condition are related to the issue reported by the customer.Visual analysis revealed that the shaft was bent and the lassostar loop was also separated form the shaft, leaving wires exposed.Costumer refer that there was resistance to insert the lassostar nav catheter to the heliostar balloon, which could be the root cause of the damage in the loop.A manufacturing record evaluation was performed for the finished device number lot 31001154l and no internal actions related to the complaint were found during the review.The issues reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use contain the following warning and precaution: insertion of the catheter into the entry port of a compatible sheath should be conducted with the insertion tool provided with the catheter.To prevent damage to the shaft of the catheter, ensure that at least half of the catheter is inserted through the sheath before sliding the insertion tool back toward the connector.In addition, do not use excessive force to advance or withdraw the catheter if resistance is encountered.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: 17398130
• MDR Text Key: 319870756
• Report Number: 2029046-2023-01587
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835020335
• UDI-Public: 10846835020335
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 09/06/2023

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: 01/31/2024
• Device Catalogue Number: D140401
• Device Lot Number: 31001154L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• 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: CARTO 3 SYSTEM; HELIOSTAR BALLOON CATHETER (3 OF THEM); LASSOSTAR NAV CATHETER (3 OF THEM)