MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) LASSO® 2515 NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D-1343-01-S

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Ischemia (1942)

Event Date 12/31/2012

Event Type  Injury  

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.Concomitant products that used in this study: carto.Other companies¿ device were used in this study: act plus (medtronic).Manufacturer's ref: (b)(4).The device is not returned to bwi.

Event Description

This complaint is from a literature source.It was reported that 102 consecutive patients suffering from symptomatic drug-refractory underwent catheter ablation between august 2011 and december 2012.Among them, one patient developed a symptomatic ischemic stroke (mesencephalic) during the procedure.Importantly, the act value was < 300 sec at t20, with an unexpected prolonged excursion below 300 sec during the procedure despite repetitive infusion of unfractionated heparin.The clinical course of the patient was favorable with complete regression of symptoms within a few weeks.This event is initially assessed as a mdr not-reportable event because carto is the only biosense webster device that was used in this study.No catheter models or brands were implicated in the article.There were no implications of any malfunctions of carto.Carto is considered a concomitant product.Additional information was received on april 28, 2017 indicating that patient required an extended hospital stay for several days but fully recovered within a few weeks.Lasso (d134301) and carto sn 10514 were used in this event.The author stated that the event was procedure related and also patient condition related (patient¿s slow anticoagulation kinetics).The event did not result in the impairment of a body function or damage to a body structure.Per additional information received, lasso is also used and considered suspect device.As such this pi is mdr reportable with new awareness date april 28, 2017.

• Brand Name: LASSO® 2515 NAV ECO VARIABLE CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6578475
• MDR Text Key: 75547991
• Report Number: 9673241-2017-00382
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2017

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-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: UNKNOWN_D-1343-01-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 05/19/2017
• 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): Life Threatening