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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded.Therefore, no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old male patient underwent an atrial fibrillation (afib) ablation procedure with a lasso® nav eco variable catheter and suffered cardiac tamponade requiring pericardiocentesis.Before the transseptal phase, pericardial effusion was noticed.Cardiac tamponade was confirmed by intracardiac echo (ice) and transthoracic echo (tte).Pericardiocentesis was performed and 170cc of fluid were removed from the pericardial space.The patient was reported in stable condition after pericardial drainage.Extended hospitalization was not required as a result of the adverse event.Patient¿s outcome is fully recovered with no residual effects.The physician¿s opinion regarding the cause of the adverse event is that the insertion of the non-bwi diagnostic decapolar catheter may have contributed to the effusion.The only biosense webster inc.(bwi) product inside the patient¿s body at the time of the adverse event was a lasso® nav eco variable catheter.There was no evidence of a steam pop.Transseptal puncture was performed with a baylis transseptal needle.A bwi ablation catheter was never introduced into the patient¿s body.No ablation was performed prior to the event.No error messages were observed on any bwi equipment during the case.It was determined that lasso® nav eco variable catheter is highly unlikely to be involved.However, it cannot be excluded completely.Therefore, the event will be conservatively reported under lasso® nav eco variable catheter.

• Brand Name: LASSO® NAV ECO VARIABLE CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9688600
• Report Number: 2029046-2020-00216
• Device Sequence Number: 14290463
• Product Code: DRF
• UDI-Device Identifier: 10846835009644
• UDI-Public: 10846835009644
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K113213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2020

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: 10/07/2022
• Device Model Number: D134302
• Device Catalogue Number: D134302
• Device Lot Number: 30300592L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 70 YR