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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent atrial fibrillation (afib) ablation procedure with lasso® nav eco variable catheter and cardiac tamponade requiring pericardiocentesis and blood transfusion.After brockenbrough [transseptal], sheath was placed and lasso® nav eco variable catheter was placed in the left atrial appendage for left atrial imaging.When the lasso® nav eco variable catheter was pulled from the left atrial appendage, the ring part stretched out so that it could be pulled on the carto3 screen, but it was pulled from the atrial appendage and removed once from the sheath.After that, left atrial imaging was performed, and after a while the blood pressure began to fall, so effusion was confirmed when confirmed by echo.Administration of noradrenaline and drainage were performed, and blood pressure was calm [stable], but blood continued to shrink [flow], so blood transfusion was performed.After continuing for about an hour, the blood finally disappeared [hemorrhage stopped] and the echo confirmed that there was no effusion, and the patient left the icu.There was no report of extended hospitalization.The physician in charge reported that they felt a little stuck when pulling lasso® nav eco variable catheter from the left atrial appendage.Since the device was removed without surgical intervention, or without using a different device the entrapment is not mdr reportable.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available in the future; the reportability decision will be reassessed.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).
Additional Manufacturer Narrative
Additional information on the event was received 10/12/2020.The patient is an 82 year old male.The physician¿s opinion is that the cause of the event is procedure.The patient had fully recovered.There was no steam pop.No error reported.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The device evaluation summary was completed on (b)(6) 2020.It was reported that a patient underwent atrial fibrillation (afib) ablation procedure with lasso® nav eco variable catheter and cardiac tamponade requiring pericardiocentesis and blood transfusion.After brockenbrough [transseptal], sheath was placed and lasso® nav eco variable catheter was placed in the left atrial appendage for left atrial imaging.When the lasso® nav eco variable catheter was pulled from the left atrial appendage, the ring part stretched out so that it could be pulled on the carto3 screen, but it was pulled from the atrial appendage and removed once from the sheath.After that, left atrial imaging was performed, and after a while the blood pressure began to fall, so effusion was confirmed when confirmed by echo.Administration of noradrenaline and drainage were performed, and blood pressure was calm [stable], but blood continued to shrink [flow], so blood transfusion was performed.After continuing for about an hour, the blood finally disappeared [hemorrhage stopped] and the echo confirmed that there was no effusion, and the patient left the icu.There was no report of extended hospitalization.The device was visually inspected, and it was found in good conditions.The magnetic and electrical features were tested and no issues were observed.In addition, the catheter was deflecting, contracting, expanding correctly.The catheter passed the outer diameter test.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instruction for use 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 reference number: (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: 10494620
• Report Number: 2029046-2020-01180
• Device Sequence Number: 2407421
• Product Code: DRF
• UDI-Device Identifier: 10846835009644
• UDI-Public: 10846835009644
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/14/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2022
• Device Model Number: D134302
• Device Catalogue Number: D134302
• Device Lot Number: 30253745L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 08/14/2020; 09/09/2020; 09/24/2020; 10/12/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 09/04/2020; 09/23/2020; 10/23/2020; 11/09/2020
• 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: Life Threatening; Required Intervention