MAUDE Adverse Event Report: BIOSENSE WEBSTER / JOHNSON AND JOHNSON LASSO 2515 NAV ECO; VARIABLE CATHETER

Model Number 2515

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problems Embolism (1829); Mitral Regurgitation (1964); Tissue Damage (2104)

Event Date 08/07/2015

Event Type  Injury  

Event Description

Biosense webster 25-15 mm variable lasso nav catheter was used and a thermocool navi-star smart df curved irrigated-tip ablation catheter into the left atrium and performed 3d mapping using the carto sound package.Successful mapping of the left common pulmonary vein, right superior pulmonary vein and right inferior pulmonary vein.Using the lasso guided technique, we performed pulmonary vein atrial isolation using a wide area circumferential ablation lesion set to isolate ipsilateral pulmonary veins en bloc.Bidirectional block was the end point in 3/3 pulmonary veins.Upon mapping with a circular mapping catheter in the right-sided pulmonary veins, the lasso catheter became dislodged toward the mitral annulus.The circular mapping catheter prolapsed into the left ventricle.As it was prolapsed we were unable to easily free it from the lv by advancing the lasso and torquing the sheath.We attempted to extend the shaft using the plunger mechanism but this was unsuccessful.Careful counterclockwise rotation of the sheath was unable to retrieve the circular mapping catheter.The sheath was then advanced to the level of the mitral annulus.Careful counterclockwise rotation of the circular mapping catheter was then used as we carefully retracted the catheter from the left ventricle.We did use intracardiac echo to verify retrieval of the catheter.New onset severe mitral regurgitation and chf noted post procedure on stat echo.Patient re-intubated, cardio thoracic surgery consulted for urgent mitral valve repair.

• Brand Name: LASSO 2515 NAV ECO
• Type of Device: VARIABLE CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER / JOHNSON AND JOHNSON; diamond bar CA 98765
• MDR Report Key: 5090807
• MDR Text Key: 26367897
• Report Number: MW5056299
• Device Sequence Number: 1
• Product Code: DRF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/16/2015

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 Expiration Date: 02/28/2018
• Device Model Number: 2515
• Device Catalogue Number: D134301
• Device Lot Number: 17212843L
• Other Device ID Number: (01) 10846835009637
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 77