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 Problem Rupture (2208)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a (b)(6)-year-old male patient underwent an unknown ablation procedure with an unknown lasso catheter and a medical device entrapment with excessive manipulation occurred and the patient suffered a cardiac valve rupture which required cardiac surgery and a mitral valve repair.During the procedure, while moving the catheter from the left sided veins to the right sided veins, the lasso catheter slipped into the ventricle, which then became caught in the mitral value.The physician was unable to get the lasso back into the atrium.Other catheters were used to help with this attempt, as well as transoesophageal echocardiography (toe) was used for visualization.The patient required cardiac surgery to remove the lasso catheter and a mitral valve repair.Prolonged hospitalization was required because of the mitral valve repair surgery.The patient was discharged from the hospital and his condition was reported to have improved.The physician¿s opinion regarding the cause of this adverse event is that this is procedure and operator error related.Since this event required interventions to prevent permanent impairment of a body function or permanent damage to a body structure, then is to be considered serious and mdr-reportable.The medical device entrapment with excessive manipulation was assessed as mdr reportable.

• Brand Name: LASSO ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11592069
• MDR Text Key: 243128674
• Report Number: 2029046-2021-00442
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 03/01/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR