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

Model Number D134903

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

Patient Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed."no code available" patient code is being used to represent the surgical intervention.A manufacturing record evaluation was performed for the finished device 30314932l 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 reference number: (b)(4).

Event Description

It was reported that a female patient (67 year old, 71kg) underwent paroxysmal (afib) ablation procedure with lasso® nav eco catheter and suffered cardiac tamponade requiring surgical intervention.It was reported that during an afib procedure, the patients' pressure dropped and a pericardial effusion was diagnosed via (ice) intracardiac ultrasound.The caller stated that the left atrial appendage (laa) was perforated when maneuvering the lasso catheter.A pericardiocentesis was performed by the physician.An appendage closure device (lariat) was being inserted at the time of the call.The catheter was discarded.In the physician¿s opinion, the cause of this adverse event was related to patient anatomy.An appendage closure device (lariat) was attempted to ligate the laa but failed.Patient was then taken for surgical repair.The patient had improved and almost fully recovered.An extended hospital stay was required due to the surgical repair.The event occurred during initial mapping.Transseptal was performed with brk needle (abbott).No ablation was performed prior to the discovery of the effusion.There was no evidence of steam pop.Since this event may be life threatening; might result in permanent impairment of a body function or permanent damage to a body structure; or required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it is mdr reportable.

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10532704
• MDR Text Key: 209625423
• Report Number: 2029046-2020-01263
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009675
• UDI-Public: 10846835009675
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2022
• Device Model Number: D134903
• Device Catalogue Number: D134903
• Device Lot Number: 30314932L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 71