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

Catalog Number D134301

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); Not Applicable (3189)

Event Date 05/07/2018

Event Type  Injury  

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.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with lasso® nav eco variable catheter x 2 and suffered a cardiac tamponade requiring surgical intervention.After transseptal puncture, lasso # 1 was inserted into the left atrium and error 116 (magnetic sensor error) and other metal errors (unspecified) populated.Metal values were within normal limits.Lasso loop was not displayed.Patient table was raised and lowered without resolution.Interface cable and 20-pole eco adapter cable were exchanged without resolution.Lasso # 1 was exchanged for lasso # 2 and the issue resolved.Mapping continued.During left atrial fast anatomical mapping (fam), lasso # 2 appeared outside of the fam shell.Pericardial effusion was detected via intracardiac echocardiography (ice).Patient became hypotensive with a systolic blood pressure in the 60s.Remainder of procedure was aborted.Pericardiocentesis yielded 800 ml.Patient was transferred to the operating room for a surgical intervention.On post-procedure day 5, the patient was reported to be extubated and in stable condition.Multiple attempts have been made to obtain clarification to this complaint.No further information has been made available.Should more information become available, the complaint will be reassessed and notes will be updated.

Manufacturer Narrative

The patient is male.Patient was transferred to the operating room for emergency open chest heart surgery with repair of the left atrial appendage perforation (laa).Patient required post-op recovery time in hospital.On post-procedure day 5, the patient was reported to be extubated and in stable condition.Patient fully recovered from surgery.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related.Transseptal puncture was performed; however, the needle product details were not provided.The generator was not in operation at the time of the event.Patient received anticoagulant (unknown) during the procedure with activated clotting time (act) of more than 300 seconds.(b)(4).

• Brand Name: LASSO® NAV ECO VARIABLE CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 7567968
• MDR Text Key: 110030932
• Report Number: 2029046-2018-01635
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (y/n): N
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/08/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: D134301
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 05/08/2018
• Supplement Dates FDA Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention