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	Entrapment of Device (1212)
Health Effect - Clinical Codes	No Code Available (3191); Unspecified Heart Problem (4454)
Date of Event	11/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.(b)(4).
Event or Problem Description
It was reported that a female patient underwent an atrial fibrillation (afib) ablation procedure with a lasso® nav eco variable catheter and medical device entrapment occurred requiring surgical intervention.During the procedure, while mapping around the mitral annulus, the lasso catheter slipped through the mitral valve and got tangled in the papillary muscles.It was not possible to remove the catheter from the papillary muscles, so the patient had to get the catheter surgically removed.In the process of the surgery, one string of papillary muscle was torn and had to be restructured within the same surgery.The ablation procedure was not completed.No fragments were generated.The patient required extended hospitalization to track her health and the surgery outcome.The patient¿s condition has improved.The physician¿s opinion on the cause of the event is it is due to an unfortunate accident that happen while mapping around the mitral valve annulus.It is not due to a malfunction of the product and not due to patient condition.
Additional Manufacturer Narrative
During an internal review on 28-feb-2023, it was decided to update this file to include coding for the h6.Health effect - clinical code of " unspecified heart problem (e0623)" which is representative of the heart injury (iatrogenic injury) experienced by the patient.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
• 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 ; 949789-8687
• MDR Report Key: 9393297
• Report Number: 2029046-2019-03941
• Device Sequence Number: 2258819
• Product Code: DRF
• UDI-Device Identifier: 10846835009644
• UDI-Public: 10846835009644
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: D134302
• Device Catalogue Number: D134302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Unknown