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

Model Number	D140401
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ¿ paroxysmal ablation procedure with a lassostar nav circular mapping catheter and internal components were exposed.It was reported that it was not possible to advance the lassostar nav circular mapping catheter through the heliostar (hs) catheter if the inflation knob was in the ¿deflated¿ mode so it was pressed to ¿inflate¿ to allow the lassostar nav circular mapping catheter pass and then pulled again to ¿deflate¿ to be able to enter into the guidestar.After the 3rd vein isolation the lassostar nav circular mapping catheter felt with bad maneuverability and was removed to inspect and noticed the plastic on the lasso was wrinkled and that a little metal needle part of a cable was exposed.The catheter was replaced.There was no patient consequence.The customer¿s reported issue of resistance with the sheath is not considered to be mdr reportable since an increased potential for patient injury is remote.This issue is reportable for the internal components exposed.
Additional Manufacturer Narrative
On 27-apr-2023, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ¿ paroxysmal ablation procedure with a lassostar nav circular mapping catheter and internal components were exposed.It was reported that it was not possible to advance the lassostar nav circular mapping catheter through the heliostar (hs) catheter if the inflation knob was in the ¿deflated¿ mode so it was pressed to ¿inflate¿ to allow the lassostar nav circular mapping catheter pass and then pulled again to ¿deflate¿ to be able to enter into the guidestar.After the 3rd vein isolation the lassostar nav circular mapping catheter felt with bad maneuverability and was removed to inspect and noticed the plastic on the lasso was wrinkled and that a little metal needle part of a cable was exposed.The catheter was replaced.There was no patient consequence.Device evaluation details: the device product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection test and dimensional inspection of the returned device.Visual analysis of the returned sample revealed that bent marks were observed on the shaft and between electrodes.Additionally, one electrode was damaged (lifted) with internal parts exposed.A dimensional test was performed, and the outer diameters of the device were found within the specifications in all of the electrodes, except the last one due to the damage observed, the measurement could not be performed.The failure observed could be related to the excessive force applied during the manipulation of the device; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed since it was observed bent marks on the shaft and damage on the electrodes.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 ref.# (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: 16827458
• Report Number: 2029046-2023-00908
• Device Sequence Number: 1931527
• Product Code: DRF
• UDI-Device Identifier: 10846835020335
• UDI-Public: 10846835020335
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2023

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: 05/16/2023
• Device Model Number: D140401
• Device Catalogue Number: D140401
• Device Lot Number: 30788644L
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 04/27/2023; 05/16/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 05/01/2023; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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: 10.5FR 28MM BALLOON ABLAT CATH; LASSOSTARNAV,10P,15MM DIA LOOP; LASSOSTARNAV,10P,15MM DIA LOOP
• Patient Sex: Unknown