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	Thrombosis (2100)
Date of Event	09/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The bwi product analysis lab received the complaint device for evaluation.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).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a redo pulmonary vein isolation (pvi) ablation procedure on which a lasso® nav eco variable catheter was used, and thrombosis occurred requiring thrombus aspiration.During the procedure, 10000 units of heparin were administered to the patient.Activated clotting time (act) was 236 seconds.Then, a thrombus was noted post lasso insertion within the left atrium (la) attached to its distal shaft (approximately 1 cm below curved lasso sensor array) between first and second transseptal puncture.Thrombus was confirmed by transesophageal echocardiography (toe).Thrombus was noted prior to the ablation catheter reaching the la.Ablation catheter was at no stage advanced into the left atrium.Nil issues noted upon connecting or flushing the ablation catheter.5000 units of heparin were administered.Act post delivery was 322.3000 u of heparin were then administered.Act post delivery was 359.The thrombus was aspirated with a medium curve agilis sheath.Reminder of the procedure was aborted.The patient did not exhibit neurological symptoms since the procedure was completed.The physician believed the amount of thrombus was excessive, the thrombus was linear independently mobile structure attached to lasso shaft, it was easily recognized on toe despite 10000u of heparin administered prior to the introduction of the lasso.Physician also considered the thrombus to be a significant risk of an embolic event.Catheter was unable to be withdrawn into sheath or back across septum prior to attempts to directly aspirate thrombus due to likelihood of ¿sheering off¿ the thrombus from the catheter.Computerized tomography (ct) of brain was done post catheter removal to exclude stroke.Extended hospitalization was not required.
Additional Manufacturer Narrative
It was reported that a 53-year-old female patient underwent a redo pulmonary vein isolation (pvi) ablation procedure on which a lasso® nav eco variable catheter was used, and thrombosis occurred requiring thrombus aspiration.The device was visually inspected, and it was found in good conditions.The magnetic feature was tested, and no issues were observed.In addition, the catheter was deflecting and contracting correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.Manufacturer's ref.No: (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.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10759350
• Report Number: 2029046-2020-01596
• Device Sequence Number: 3333644
• Product Code: DRF
• UDI-Device Identifier: 10846835009644
• UDI-Public: 10846835009644
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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: 04/20/2023
• Device Model Number: D134302
• Device Catalogue Number: D134302
• Device Lot Number: 30384438L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDIUM CURVE AGILIS SHEATH; UNKNOWN ABLATION CATHETER
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 59 YR