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

Catalog Number D134301

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2019

Event Type  malfunction  

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.Manufacturing record evaluation (mre) review cannot be conducted because no lot number was provided by the customer.Manufacturer's reference # (b)(4).

Event Description

It was reported that a patient underwent an atrial tachycardia (at) procedure with a lasso® nav eco variable catheter and it was described that the catheter tip was tied into a knot.It was reported that when the case was completed, all catheters had been pulled from the left atrium to the right atrium.The lasso® nav eco variable catheter had been removed from the body.Then the physician induced an atrial tachycardia arrhythmia and advanced the lasso® nav eco variable catheter.The physician then decided not to use the lasso® nav eco variable catheter and pulled the catheter out of the body, but he couldn't pull it fully into the sheath.On fluoroscopy, it showed the catheter tip was tied into a knot.It was noted that it must have knotted when the physician went to advance it into the coronary sinus.In addition to the lasso® nav eco variable catheter in the coronary sinus vessel, there was also a coronary sinus catheter as well.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The knotted loop issue is considered a reportable event.

• Brand Name: LASSO® NAV ECO VARIABLE CATHETER
• Type of Device: 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 ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8316312
• MDR Text Key: 137732076
• Report Number: 2029046-2019-02657
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134301
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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