MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) LASSO® 2515 NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D-1343-02-S

Device Problems Entrapment of Device (1212); Knotted (1340); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2016

Event Type  malfunction  

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.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.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 Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a lasso 2515 nav eco variable catheter and suffered a medical device entrapment requiring catheter manipulation.Near the end of the case, the lasso became fixed in the left atrium.The physician used fluoroscopy and 3d transesophageal echocardiography (tee) to visualize the lasso, which appeared to be in a knot.Under fluoroscopy and tee, it also appeared that the lasso picked up a piece of atrial tissue, thought to be trabeculae (supporting bundles of muscular fibers).It was noted that the tissue was not thought to be from the mitral valve apparatus or the septal wall.Initially, the physician was not able to free the catheter and plans were made for a surgical intervention.With further manipulation, the physician was able to remove the knot and free the catheter with no harm to the patient.After the case, upon visual inspection, the catheter appeared to be structurally intact and without damage.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This event has been assessed as mdr reportable because a knotted lasso loop can potentially cause patient injury.

• Brand Name: LASSO® 2515 NAV ECO VARIABLE 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: 5667970
• MDR Text Key: 46691257
• Report Number: 9673241-2016-00337
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K113213
• 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: 04/22/2016

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 Expiration Date: 01/31/2019
• Device Model Number: D-1343-02-S
• Device Catalogue Number: D134302
• Device Lot Number: 17419129L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/19/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2016
• 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