MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_LASSO

Catalog Number UNK_LASSO

Device Problem Entrapment of Device (1212)

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: 2029046-2021-01110 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 during the ablation confirmation procedure, catheter movement was met by severe resistance.Based on the previous experience, surgery was undertaken immediately.Left atrial exploration revealed the catheter was severely entangled within the lateral commissure of the mv.A chorda rupture at the middle portion of the anterior mv leaflet (a2) and tearing of the p1 scallop resulted in significant mv regurgitation.Multiple monofilament sutures for the p1 scallop repair and new chorda formation for the a2 portion were followed by implantation of a 28-mm carpentier-edward ring.Intraoperative tee showed trace mitral regurgitation.Serial echocardiograms showed the minimal mitral regurgitation to be durable and the patient 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 and 28-mm carpentier-edward 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 92618 ; 949789-868
• MDR Report Key: 12163435
• MDR Text Key: 261432886
• Report Number: 2029046-2021-01111
• 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

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_LASSO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2021
• 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: 48 YR