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

Catalog Number	D140402
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
On 28-aug-2023, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.Additionally, photo analysis of the 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 severely damaged, 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 30914131l 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
• Common Device Name: 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: 17394054
• Report Number: 2029046-2023-01588
• Device Sequence Number: 17625175
• Product Code: DRF
• UDI-Device Identifier: 10846835020342
• UDI-Public: 10846835020342
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K211219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/29/2023
• Device Catalogue Number: D140402
• Device Lot Number: 30914131L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; HELIOSTAR BALLOON CATHETER (3 OF THEM); LASSOSTAR NAV CATHETER (3 OF THEM)
• Patient Sex: Unknown