MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) LASSO; GENERIC - LASSO

Model Number D-1220-00

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

Patient Problems Death (1802); Transient Ischemic Attack (2109); Thromboembolism (2654)

Event Date 05/31/2016

Event Type  Death  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.Other company¿s devices were used during this study: an irrigated unipolar rf ablator (visitrax, ncontact surgical, (b)(4)); an intracardiac echocardiographic guide (acunav; acuson, (b)(4)).(b)(4).The device was not returned to bwi.

Event Description

This complaint is from a literature source.It was reported that one patient in the hybrid procedure group died from a fatal stroke.This (b)(6) man developed a large thromboembolic stroke after 5 days, and died within 2 weeks of the procedure.Additional information was received on 09/27/2016 indicating that the author assessed most of the complications were due to the surgical procedure.Title: "hybrid procedure (endo/epicardial) versus standard manual ablation in patients undergoing ablation of longstanding persistent atrial fibrillation: results from a single center." the purpose of this study was to evaluate the differences in success and complications, between a combined concomitant surgical/endocardial procedure via pericardial access, and their standard endocardial approach, in the treatment of standalone lspaf.Fifty-nine (59) patient were enrolled in this study.An irrigated unipolar rf ablator (visitrax, ncontact surgical, (b)(4)); and a circular mapping catheter (biosense webster, (b)(4)); and an intracardiac echocardiographic guide (acunav; acuson, (b)(4)) were used in this study.Bwi takes conservative approach to open this complaint under the circular mapping catheter, however catalog and lot number are unknown.

• Brand Name: LASSO
• Type of Device: GENERIC - LASSO
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6001031
• MDR Text Key: 56504875
• Report Number: 2029046-2016-00173
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2016

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 Model Number: D-1220-00
• Device Catalogue Number: D122000
• Device Lot Number: UNKNOWN_LASSO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR