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

Model Number	D134903
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); No Code Available (3191)
Date of Event	08/17/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: 10532704
• Report Number: 2029046-2020-01263
• Device Sequence Number: 3056068
• Product Code: DRF
• UDI-Device Identifier: 10846835009675
• UDI-Public: 10846835009675
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K113213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/14/2020
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 71