MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER; CATHETER, ELECTRODE RECORDING

Model Number	D7L102515RT
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).(b)(4).
Event or Problem Description
It was reported that a patient underwent atrial fibrillation (afib) ablation procedure with a lasso¿ 2515 variable circular mapping catheter and suffered cardiac tamponade requiring medication.While mapping the atrium with the ablation catheter, a pericardial effusion occurred.No excessive contact force was noted.An echo exam was performed which revealed a pericardial effusion.No drain was placed and only medication was administered to stabilize the patient.Procedure was stopped.No additional patient adverse event.Since intervention was required to stabilize the patient and the procedure was aborted this event will be conservatively reported under the lasso catheter.
Additional Manufacturer Narrative
On 2/4/2021, the product investigation was completed as the complaint device was not received.It was reported that a patient underwent atrial fibrillation (afib) ablation procedure with a lasso¿ 2515 variable circular mapping catheter and suffered cardiac tamponade requiring medication.While mapping the atrium with the ablation catheter, a pericardial effusion occurred.No excessive contact force was noted.An echo exam was performed which revealed a pericardial effusion.No drain was placed and only medication was administered to stabilize the patient.Procedure was stopped.No additional patient adverse event.Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device with lot number 30251404l, and no internal actions related to the reported complaint condition were identified.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 2515 VARIABLE CIRCULAR MAPPING CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 9947518
• Report Number: 2029046-2020-00534
• Device Sequence Number: 11587308
• Product Code: DRF
• UDI-Device Identifier: 10846835000306
• UDI-Public: 10846835000306
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K031161
• 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): 03/18/2020

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: 07/08/2022
• Device Model Number: D7L102515RT
• Device Catalogue Number: D7L102515RT
• Device Lot Number: 30251404L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 02/04/2021
• 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