MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) LASSO; CATHETER, ELECTRODE RECORDING

Model Number LASSO

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

Patient Problems Air Embolism (1697); Hematoma (1884); Laceration(s) (1946); Transient Ischemic Attack (2109); Cardiac Tamponade (2226); Pseudoaneurysm (2605); No Code Available (3191)

Event Date 03/01/2013

Event Type  Injury  

Event Description

Article title: how to learn pulmonary vein isolation with a novel ablation device: learning curve effects using the endoscopic ablation system.Per a report in the journal cardiovasc electrophysiol.2014 jul 28.Doi: 10.1111/jce.12491.[epub ahead of print], a single-center prospective study was conducted on 150 patients, by perrotta, l.Of the cardioangiologisches centrum bethanien et al., to determine the safety, efficacy and learning curve effects of eas-pvi in a large volume single center.Clinical follow-up time: 12 months.From the report there were 6 serious adverse events: one pericardial tamponade was drained percutaneously and the patient¿s clinical course was uneventful.In one patient from t 1 a transient ischemic attack (tia) occurred, most likely due to air embolism, but completely resolved during the hospital stay.There was one vascular access complications requiring surgery: one patient underwent surgical repair of a femoral venous laceration.Phrenic nerve palsy was observed in 3 patients.Phrenic nerve function had recovered in all patients after a 3-months follow-up.Per the article, other non-serious ae¿s were also reported: there were 5 vascular access complications: one groin hematoma and 4 pseudoaneurysm.These events are not known to have required intervention/treatment nor extended hospitalization stay.If additional information is received, we will update information in a supplemental report.There are no death events and no device malfunctions reported in the publication.Model and catalog number are not available.The ablation device tested was a non biosense webster product, however, a biosense webster circular mapping catheter was used in all procedures.Therefore, the suspected device is the lasso.

Manufacturer Narrative

(b)(4).

• Brand Name: LASSO
• Type of Device: CATHETER, ELECTRODE RECORDING
• 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: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4082558
• MDR Text Key: 22143991
• Report Number: 2029046-2014-00298
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K002333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/19/2014

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: LASSO
• Device Lot Number: UNKNOWN_LASSO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2014
• Initial Date FDA Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 64 YR