MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO® NAV ECO CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D134301

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

Patient Problem Rupture (2208)

Event Date 03/09/2022

Event Type  Injury  

Manufacturer Narrative

Device investigation details: 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.A manufacturing record evaluation was performed for the finished device 30705429l number, and no non-conformances related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a lasso® nav eco catheter and the catheter got stuck on the mitral valve requiring surgical intervention.During the mapping phase, the lasso catheter got stuck on the mitral valve.The procedure had to be interrupted and the patient underwent surgery to remove the catheter.The patient¿s mitral annulus was removed and a biological valve was implanted.The lasso® nav eco catheter got stuck in contracted position; the physician wasn¿t able to unfold it.It is unknown if the knob/piston was able to be turned and/or pushed up and down.The patient had to undergo surgery in order to remove the catheter from his heart.The sheath used was a heartspan 71cm.The atrial fibrillation (afib) ablation procedure was not successfully completed.The patient had to be transferred in order to undergo a surgery.His mitral valve had to be replaced by a biological valve prosthetist.The patient¿s outcome from the adverse event was reported as unchanged.

• Brand Name: LASSO® NAV ECO 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 ; 6465917981
• MDR Report Key: 14017516
• MDR Text Key: 289667928
• Report Number: 2029046-2022-00732
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: D134301
• Device Catalogue Number: D134301
• Device Lot Number: 30705429L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization