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

Catalog Number	D134302
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.(b)(4).A manufacturing record evaluation was performed for the finished device 30134583l number, and no internal action was found during the review.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure on which a lasso® nav eco variable catheter was used, and a medical device entrapment occurred requiring surgical intervention.After pvi was completed, the lasso® nav eco variable catheter was moved to the left pulmonary vein (lpv) from the right pulmonary vein (rpv) and got caught in the chorda tendineae.The catheter was attempted to be released, and as a result the chorda tendineae was torn off.The patient¿s pulse rate fell from 90 to 80, but then returned to 100 bpm.Extended hospitalization was required to observe patient¿s progress.On post-procedure day 4, a mitral valvuloplasty was performed successfully.There¿s no information regarding the physician¿s causality opinion.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.This medical device entrapment was assessed as reportable as any incident where there is difficulty removing a catheter from the patient¿s body whether it is stuck inside or become tangled with another catheter and surgical intervention is required or serious injury occurred, then it is to be considered mdr-reportable.
Additional Manufacturer Narrative
Additional information was received on the event on march 12, 2019.The patient was a 40-year-old male and weighed 80 kgs.Patient¿s outcome is improved.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related.Therefore, added patient age at the time of event, age unit, sex, weight of the patient and weight unit.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: 8397913
• Report Number: 2029046-2019-02758
• Device Sequence Number: 16248376
• 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
• Report Date (Section B): 02/12/2019

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 Expiration Date: 10/24/2021
• Device Catalogue Number: D134302
• Device Lot Number: 30134583L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 03/26/2019
• 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: 40 YR
• Patient Weight: 80