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

Catalog Number	D134302
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The device history record (dhr) for the lot number 30044783l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation with lasso® nav eco variable catheter and suffered a medical device entrapment requiring a surgical intervention.During the procedure, the lasso® nav eco variable catheter was maneuvered from the left atrium to the left ventricle via the mitral valve.In doing so, the lasso® nav eco variable catheter became entrapped in the mitral chordae tendinae.Physician was unable to maneuver the lasso® nav eco variable catheter out of the left ventricle.A surgical intervention was performed to release the medical device entrapment.There is no information about the hospitalization.It was noted that the adverse event was not the result of any catheter malfunction.There were no issues, errors, or malfunctions reported on any biosense webster, inc.Products or equipment during the procedure.The physician did not provide a causality opinion for the cause of this adverse event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, this is mdr reportable since a surgical intervention was required to resolve the medical device entrapment, this is mdr reportable.

• Brand Name: LASSO® NAV ECO VARIABLE CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7697313
• Report Number: 2029046-2018-01803
• Device Sequence Number: 16392792
• Product Code: DRF
• UDI-Device Identifier: 10846835009644
• UDI-Public: 10846835009644
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/12/2021
• Device Catalogue Number: D134302
• Device Lot Number: 30044783L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention