MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO¿ 2515 VARIABLE CIRCULAR MAPPING; CATHETER, ELECTRODE RECORDING

Catalog Number	D7L102515RT
Medical Device Problem Codes	Entrapment of Device (1212); Material Frayed (1262); Knotted (1340); Device Operational Issue (2914)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The device history record(s) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Concomitant products include: non-bwi products: st.Jude medical 8 french sl0 sheath.(b)(4).(b)(6).
Event or Problem Description
It was reported that a (b)(6) male patient underwent a pulmonary vein isolation (pvi) ablation procedure for atrial fibrillation with a lasso¿ 2515 variable circular mapping catheter and suffered a medical device entrapment requiring surgical intervention.At the beginning of the procedure, prior to ablation, the lasso catheter became entrapped deep in the left atrial appendage (laa).In an attempt to free the lasso catheter, the device was rotated, resulting in further entanglement.Sheath was advanced over the lasso catheter in an attempt to retrieve it.At this point, the lasso loop stretched and was released from the laa.Procedure continued.Upon maneuvering to the right pulmonary veins, the lasso loop became entrapped in the septum.When the physician attempted to maneuver the lasso catheter through the septum, the loop formed a knot.It was then determined that the loop was damaged and the mechanism was not functioning properly.Physician attempted to retrieve the lasso catheter via snare without success.Physician attempted to maneuver the sheath over the knotted tip without success.Subsequently, the lasso catheter was forcefully pulled from the left atrium into the right atrium via the septum.The lasso catheter was then pulled to the groin area.A tissue cut-down was performed and the lasso catheter was removed.It was noted that there were exposed wires.Procedure delay was 30-60 minutes.The reported catheter contraction issue is not a reportable malfunction, however, since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.The issues of medical device entrapment, knotted loop and broken tip are all considered reportable malfunctions.

• Brand Name: LASSO¿ 2515 VARIABLE CIRCULAR MAPPING
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7489129
• Report Number: 2029046-2018-01519
• Device Sequence Number: 13734153
• Product Code: DRF
• UDI-Device Identifier: 10846835000306
• UDI-Public: 10846835000306
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K031161
• 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): 04/04/2018

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: 09/17/2020
• Device Catalogue Number: D7L102515RT
• Device Lot Number: 17737707L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 05/04/2018
• 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: Other; Required Intervention
• Patient Age: 72 YR