MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_LASSO

Catalog Number UNK_LASSO

Device Problems Entrapment of Device (1212); Separation Problem (4043)

Patient Problems Rupture (2208); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 12/31/2006

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No : (b)(4).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 lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Biosense webster report number: 2029046-2021-01111 is related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that a (b)(6)-year-old man with a history of recurrent symptomatic episodes of paroxysmal af underwent pv isolation and left atrial circumferential ablation with the lasso circular mapping catheter and ablation catheter and although successful ablation was confirmed catheter movement was met by resistance that prohibited further attempts at removal.Transesophageal echocardiography (tee) revealed entrapment of the catheter tip in the mv apparatus.Traction and clockwise and counterclockwise rotation maneuvers to release the tip resulted in its fracture at the very proximal portion.Emergency operation was indicated to remove the catheter and repair any mv injuries that may have occurred.The posterior leaflet between the middle (p2) and lateral (p1) scallops was torn and a chorda rupture at the lateral scallop of the posterior mv leaflet was found.The mapping catheter tip was severely entangled within the mv chordae and the anterolateral papillary muscle.Because successful ablation was confirmed perioperatively, no further surgical ablation was conducted.Intraoperative tee showed a mild (grade 2/4) degree of residual mitral regurgitation, necessitating re-institution of cardiopulmonary bypass for subsequent implantation of a 27-mm tailor annuloplasty ring (st jude medical inc, st.Paul, mn, usa).Residual mitral regurgitation was no longer observed in the post-repair intraoperative tee.The patient fully recovered from surgery and remained in normal sinus rhythm during follow-up.Model and catalog number are not available, but the suspected device is lasso.Other biosense webster devices that were also used in this study: none.Non-biosense webster devices that were also used in this study: aesop 3000 , 27-mm tailor annuloplasty ring.Publication details: title: minimally invasive surgical release of entrapped mapping catheter in the mitral valve.Objective: two cases of catheter entrapment in the mitral valve, which is a rare complication of pulmonary vein isolation, were successfully treated via robot-assisted minimally invasive surgery.Methods: review of 2 cases of entrapment.

• Brand Name: UNK_LASSO
• Type of Device: UNK
• 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12163439
• MDR Text Key: 261434025
• Report Number: 2029046-2021-01110
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2021

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 Catalogue Number: UNK_LASSO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/13/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR