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

Catalog Number D134301

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Date 10/16/2017

Event Type  Injury  

Manufacturer Narrative

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 (dhr) 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.Manufacturer's ref.(b)(4).

Event Description

It was reported that a (b)(6), female patient underwent an ablation procedure for paroxysmal atrial fibrillation with a lasso® nav eco variable catheter and suffered a pneumothorax.During the procedure, blood was observed in the endotracheal tube.Chest x-ray revealed a collapsed right upper lobe of the lung.Remainder of procedure was aborted.Patient was transferred to the intensive care unit (icu).Multiple attempts have been made to obtain clarification to this complaint.No further information has been made available.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 1/16/2018.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

It was reported that a (b)(6), female patient underwent an ablation procedure for paroxysmal atrial fibrillation with a lasso® nav eco variable catheter and suffered a pneumothorax.The returned device was visually inspected and it was found in normal conditions.The catheter was evaluated for carto 3 functionality and it was recognized by the system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.Then, the catheter was tested for electrical performance and it was found within specifications.Additionally, a deflection and contraction test were performed and the catheter passed the tests.The device history record (dhr) 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.The catheter passed all specifications.The root cause of the adverse event remains unknown.(b)(4).

• Brand Name: LASSO NAV
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7006875
• MDR Text Key: 91246198
• Report Number: 2029046-2017-01110
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: (01)10846835009637(11)170725(17)200630(10)17711509L
• Combination Product (y/n): N
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2017

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: 06/30/2020
• Device Catalogue Number: D134301
• Device Lot Number: 17711509L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Initial Date Manufacturer Received: 10/16/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 10/16/2017; 10/16/2017
• Supplement Dates FDA Received: 01/17/2018; 03/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR