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

Model Number D134901

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

Additional 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 30392522l number, and no internal action 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 (b)(6) male patient underwent an atrial fibrillation (afib) ablation procedure on (b)(6) 2020 and a lasso® nav eco catheter become entrapped in the ventricular chordae tendineae requiring surgical intervention to be removed.During the procedure, when creating the left atrial modeling, the lasso catheter fell into the ventricle and become entrapped in the chordae tendineae.The catheter could not be pulled out.After two hours of rotating the catheter, it could be withdrawn from the patient¿s body; however, the end of the catheter was broken and remained entrapped in the chordae tendineae.On (b)(6) 2020, the patient underwent guidance thoracoscopic surgery, and the lasso tip was removed from the patient¿s body.Additional information indicated that the knob/piston was unable to be turned and/or pushed up and down.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available, it will be reviewed and processed accordingly.

Manufacturer Narrative

It was reported that a 53-year-old male patient underwent an atrial fibrillation (afib) ablation procedure on (b)(6) 2020, and a lasso® nav eco catheter become entrapped in the ventricular chordae tendineae requiring surgical intervention to be removed.Device investigation details: pictures were provided by customer to aid in the investigation.The pictures how the lasso tip appears detached from the shaft.Based on the picture analysis, the customer complaint was confirmed.The root cause of adverse event is unknown.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.A manufacturing record evaluation was performed, and no internal action related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: LASSO NAV ECO CATHETER
• 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: 11184367
• MDR Text Key: 227742248
• Report Number: 2029046-2021-00075
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009651
• UDI-Public: 10846835009651
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2023
• Device Model Number: D134901
• Device Catalogue Number: D134901
• Device Lot Number: 30392522L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR