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

Catalog Number UNK_LASSO

Device Problems Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problems Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 09/16/2006

Event Type  Injury  

Event Description

This complaint is from a literature source: kesek m, englund a, jensen sm, jensen-urstad m.Entrapment of circular mapping catheter in the mitral valve.Heart rhythm.2007 jan;4(1):17-9.Doi: 10.1016/j.Hrthm.2006.09.016.Epub 2006 sep 16.Pmid: 17198983.Objective/methods/study data: the purpose of this study was to evaluate patients with entrapment.They described three patients with entrapment during ablations for atrial fibrillation.The entrapments occurred with three different operators at three different electrophysiological laboratories within 2 years.The complication described here may be more common than is widely appreciated.Patient 1 is a 41-year-old man with a 5-year history of paroxysmal atrial fibrillation.Patient 2 is a 56-year-old man with paroxysmal atrial fibrillation of more than 10 years.Patient 3 is a 62-year-old man with a 9-year history of daily episodes of paroxysmal atrial fibrillation refractory to antiarrhythmic drugs.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: 20-pole deflectable 7-fr 20-mm circular mapping catheter (lasso).12-mm lasso catheter.10-pole deflectable 7-fr 10-mm circular mapping catheter (lasso).This all will be coded as unk_lasso.Other biosense webster concomitant devices that were also used in this study: n/a.Non-biosense webster devices that were also used in this study: localisa navigation system (medtronic, minneapolis, mn).8-fr cryoablation catheter (freezormax, cryocath,montreal).Long sheath (fastcath 8 fr, sl1, st.Jude medical, daig, minnetonka, mn).Long sheet (daig sl1).Adverse event(s) and provided interventions: qty 1 the 20-mm circular mapping lasso catheter became firmly attached at the atrioventricular plane level and the operator was unable to remove it by rotation or extraction through application of reasonable traction force- surgical intervention.Qty 1-12-mm lasso catheter- cather attached to the posterior part of the mitral valve- surgical intervention.Qty 1- 10-pole deflectable 7-fr 10-mm circular mapping catheter (lasso)-dislocation of the lassa catheter.And became attached to the mitral valve.Mitral valve tear was also noted- surgical intervention.

Manufacturer Narrative

This complaint is from a literature source: kesek m, englund a, jensen sm, jensen-urstad m.Entrapment of circular mapping catheter in the mitral valve.Heart rhythm.2007 jan;4(1):17-9.Doi: 10.1016/j.Hrthm.2006.09.016.Epub 2006 sep 16.Pmid: 17198983.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Biosense webster manufacturer's reference number (b)(4) has three reports: (2) mfr # 2029046-2022-02347 for product code unk_lasso (lasso¿ electrophysiology catheter) (3) mfr # 2029046-2022-02348 for product code unk_lasso (lasso¿ electrophysiology catheter).

• Brand Name: LASSO¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15514397
• MDR Text Key: 300904682
• Report Number: 2029046-2022-02346
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_LASSO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 8-FR CRYOABLATION CATHETER (FREEZORMAX, CRYOCATH); LOCALISA NAVIGATION SYSTEM (MEDTRONIC); LONG SHEATH (FASTCATH 8 FR, SL1, ST. JUDE MEDICAL); LONG SHEET (DAIG SL1)
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male