MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO® NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number	D134302
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an afib - paroxysmal ablation procedure involving a lasso® nav eco variable catheter and suffered a cardiac tamponade requiring a pericardiocentesis.It was reported that during the procedure, the doctor said that the catheter curve was broken.Surgery was not delayed due to the reported event.Action taken when event occurred was to change catheter.Procedure was not successfully completed.It was also reported that there was cardiac tamponade and pericardial puncture was performed.Additionally, it was reported this adverse event discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was procedure related.Intervention provided was epicardial puncture.Transseptal puncture performed with 301803m preface.Ablation was not performed prior to noting the cardiac tamponade; therefore, no evidence of steam pop.Event occurred during mapping phase.The flow setting for the irrigated catheter was 40w 2cc-15cc.Correct catheter settings were selected on the generator.Pump was switching from ¿low¿ to ¿high¿ flow during ablation.Force visualization features used were vector and visitag.No additional filter was used.
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 30883528l and no internal action related to the complaint was found during the review.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: LASSO® NAV ECO VARIABLE 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: 16616269
• Report Number: 2029046-2023-00631
• Device Sequence Number: 17710319
• Product Code: DRF
• UDI-Device Identifier: 10846835009644
• UDI-Public: 10846835009644
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K113213
• 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
• Report Date (Section B): 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2025
• Device Model Number: D134302
• Device Catalogue Number: D134302
• Device Lot Number: 30883528L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• 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: PREF.GUIDING SHEATH W/MULT.CRV; UNK CATHETER; UNK_CARTO 3
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 85 KG