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

Catalog Number	D134302
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Rupture (2208); No Code Available (3191)
Date of Event	12/14/2017
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.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation with a lasso nav catheter and suffered a cardiac valve rupture requiring surgical intervention.During the procedure, the lasso nav catheter became entrapped in the mitral valve.Lasso nav catheter was successfully removed.Patient required a mitral valve replacement.Patient was reported to be in stable condition.Multiple attempts have been made to obtain additional information regarding this event, but none has been made available.
Additional Manufacturer Narrative
On (b)(6) 2017, (b)(6) received additional information regarding this event: the patient was a (b)(6) year-old female.Patient was reported to be in stable condition.Patient required extended hospitalization as a result of the adverse event for surgical recovery.Physician¿s opinion regarding the cause of the adverse event is that it was related to procedure and patient condition.Manufacturer's reference number: (b)(4).

• Brand Name: LASSO NAV
• 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: 7169925
• Report Number: 2029046-2018-01021
• Device Sequence Number: 2116913
• Product Code: DRF
• UDI-Device Identifier: 10846835009644
• UDI-Public: (01)10846835009644(11)171027(17)201026(10)17753202L
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 12/14/2017

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: 10/26/2020
• Device Catalogue Number: D134302
• Device Lot Number: 17753202L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 01/29/2018
• 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; Required Intervention
• Patient Age: 61 YR