MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number	D7L1015RT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	02/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a (b)(6) male patient underwent an unknown ablation procedure with a pentaray nav high-density mapping eco catheter and a lasso¿ electrophysiology catheter.The patient suffered cardiac tamponade (ct) requiring pericardiocentesis and prolonged hospitalization.It was reported that a bb (transeptal puncture) and left atrial angiography (lag) were conducted.The lasso and pentaray were placed to the left atrium (la).The patient was in atrial fibrillation on the ecg monitor and blood pressure was low.The patient was checked for a pericardial effusion which was confirmed when chest wall echo was performed.Pericardiocentesis was performed and the patient left the room at that time the pericardial effusion was minimal on echocardiography.Ablation was never performed as the cardiac tamponade occurred during the mapping phase.The patient was under observation.The physician commented that there was no problem with the product.The sheaths used in the case were two sl0 and one agilis small 5fr short sheath.The transeptal puncture was performed with a rf needle large curve c1.Persistent left superior vena cava (plsvc) was checked on the ct, there was no problem with the biosense webster inc.(bwi) product.Cardiac rehabilitation was performed because the patient had resting time.No ablation catheter was used in the procedure as the cardiac tamponade occurred before the insertion of an ablation catheter into the patient's body.At that point physician decided not to perform ablation.The physician¿s opinion on the cause of this adverse event was that it was not related with the bwi product.The patient outcome of the adverse event was reported as improved.The generator intended to be used was a smartablate but no ablation was done.Prior to noting the cardiac tamponade, ablation was not performed; therefore, no steam pop occurred.No error messages were observed on the biosense webster equipment.This adverse event was discovered during use of biosense webster products.Extended hospitalization was required because of cardiac rehabilitation.No relevant tests/laboratory data and no other relevant medical history.This event did not occur with incorrect generator setting.It was not reported that flow switching issue occurred.The ablation catheter was not used so no force visualization features were used.Conservatively, this will be reportable on the lasso and pentaray catheters as they were in the patient¿s heart at the time of the injury.Should more information become available, this will be reviewed and processed accordingly.
Additional Manufacturer Narrative
Initial reporter phone: (b)(6) if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports: mfr # 2029046-2022-00450 for product code d128211 (pentaray nav high-density mapping eco catheter).
Additional Manufacturer Narrative
Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30675262l number, 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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2022-00449 for product code d7l1015rt (lasso¿ electrophysiology catheter) (2) mfr # 2029046-2022-00450 for product code d128211 (pentaray nav high-density mapping eco catheter).

• Brand Name: LASSO¿ ELECTROPHYSIOLOGY 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13666549
• Report Number: 2029046-2022-00449
• Device Sequence Number: 17332307
• Product Code: DRF
• UDI-Device Identifier: 10846835000283
• UDI-Public: 10846835000283
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2022

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: 10/24/2024
• Device Model Number: D7L1015RT
• Device Catalogue Number: D7L1015RT
• Device Lot Number: 30675262L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 04/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2021
• 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: CARTO 3 SYSTEM WITH CARTO MERGE; PENTARAY NAV ECO 7FR, D, 2-6-2; UNK AGILIS SMALL 5FR SHORT SHEATH; UNK RF NEEDLE LARGE CURVE C1; UNK SL0 SHEATH; UNK SL0 SHEATH; UNK_SMARTABLATE GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male