MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) LASSO® NAV CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D-1312-01-S

Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 03/26/2017

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.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.The device history record (dhr) for the lot number 17611218l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.Concomitant medical product: non biosense webster, inc.- (b)(4) sheath.(b)(4).

Event Description

It was reported that a (b)(6) male patient underwent an ablation procedure for paroxysmal atrial fibrillation with a lasso sas catheter and suffered a medical device entrapment requiring surgical intervention.During the procedure, the catheter tip slid from the left atrium into the left ventricle and became entrapped.Clockwise rotation was unsuccessful.A st.Jude medical sheath was used for support, but the tip detached from the catheter and remained in the left ventricle during catheter removal attempts.Remainder of procedure was aborted.Patient required extended hospitalization as a result of the adverse event.Patient outcome is worsened, as a surgical intervention will be necessary for catheter tip removal.No postoperative discomfort was noted.Physician did not provide a 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.

• Brand Name: LASSO® NAV CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6508794
• MDR Text Key: 73331589
• Report Number: 9673241-2017-00302
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: D-1312-01-S
• Device Catalogue Number: DLN1215CT
• Device Lot Number: 17611218L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• 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; Required Intervention
• Patient Age: 51 YR