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

Model Number	D134302
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent cardiac ablation procedure with a lasso® nav eco variable catheter where thrombus occurred.Clot formed on shaft of the lasso® nav eco variable catheter.Case abandoned.No patient consequence.The transeptal puncture was performed.The lasso® nav eco variable catheter was passed into the left atrium whilst preparing for a second pass it was noted by the transoesophageal echocardiography physician that there was a clot on the shaft of the lasso® nav eco variable catheter.The system did not present any error messages.The patient was anticoagulated ((b)(4)).The patient was under general anesthesia for approx.2 hours.In the physician¿s opinion cancelation of the procedure could not contribute to a death or a serious injury to the patient.Extended hospitalization was not required.Procedure was aborted due to thrombus formation and risk of embolism.
Additional Manufacturer Narrative
It was reported that a patient underwent cardiac ablation procedure with a lasso® nav eco variable catheter where thrombus occurred.Clot formed on shaft of the lasso® nav eco variable catheter.Case abandoned.No patient consequence.Device evaluation details: on (b)(6) 2020, the bwi product analysis lab received the complaint device for evaluation and the evaluation has been completed.Upon receipt, the catheter was visually inspected and it was found in normal conditions: no trails of thrombus were observed.A manufacturing record evaluation was performed for the finished device number and no internal action related to the complaint was found during the review.The customer complaint cannot be duplicated as intended.There is no evidence of thrombus residues were observed on the catheter.The device was found in normal conditions.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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 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: 10849329
• Report Number: 2029046-2020-01757
• Device Sequence Number: 13670783
• Product Code: DRF
• UDI-Device Identifier: 10846835009644
• UDI-Public: 10846835009644
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2023
• Device Model Number: D134302
• Device Catalogue Number: D134302
• Device Lot Number: 30352694L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1