MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) LASSO NAV DUO LOOP ECO CATHETER; ELECTRODE RECORDING CATHETER

Model Number D-1354-04-S

Device Problems Entrapment of Device (1212); Difficult To Position (1467); Difficult to Remove (1528); Retraction Problem (1536)

Patient Problem No Code Available (3191)

Event Date 06/05/2014

Event Type  Injury  

Event Description

It was reported that a patient, (b)(6) years old, female, underwent a paroxysmal af ablation procedure with a duolasso catheter suffered a medical device entrapment.After creating a fam shell with the duolasso catheter, the physician began ablating on the right pulmonary veins.After complete isolation of the right veins, the physician maneuvered the duolasso catheter to the left superior pulmonary vein (lspv), when doing so the catheter went into the left ventrical.The physician attempted to maneuver, clockwise torque the catheter and retract.The catheter loop was not responding to the manipulation of the catheter, and after approximately 10 minutes.Into the removal attempt, it was noticed that the loop of the lasso had separated from the shaft of the catheter and immediately informed the physician.The entrapment was observed on the carto 3 system and fluoro.The physician tried to retract the lasso catheter from the mitral valve and part of the lasso catheter started to detach from the catheter and the wire was visible on fluoro.The physician stopped the removal attempt and called the cardiac surgeon for a consult.The patient required surgical intervention to remove the duolasso catheter from the mitral cordae.The surgeon reported post procedure that the loop of the catheter was tied in two separate knots around two separate cordae.The event required hospitalization.The electrophysiologist reported the next day that the patient was going to make a full recovery.During the surgical workup, in the ep lab, the coronary arteries were assessed, and it was determined that the patient was in need of a bypass surgery for coronary artery disease as well.The physician¿s opinion regarding the causality of adverse event was device-related.

Manufacturer Narrative

The device history record(s) 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.In the ifu is stated: to reduce the risk of entrapping cardiac structures in the mapping electrode portion of the catheter, place the lasso® nav duo loop eco catheter by torquing (or rotating) the shaft in a clockwise motion only.To prevent entanglement of the catheter with the valves and to prevent slippage of the catheter into the ventricles, care should be taken when using the catheter in or around the atrial ¿ ventricle valve region.Bwi equipment in use: carto 3 system: 14215, stockert generator: st-1993, coolflow pump: 02158, thermocool catheter: d132704 (lot #16093484m).(b)(4).

Manufacturer Narrative

(b)(4) it was reported that during a procedure the catheter became trapped and the patient required surgical intervention.Bwi requested to receive the complaint sample for investigation however the catheter was not returned but the hospital agreed that bwi representatives could inspect the catheter on- site.The following is the summary of on-site investigation, from the pictures which the bwi representative took from defected catheter: the catheter tip had been cut into several pieces to extract it from mitral valve apparatus it is assumed that wire cutters or pliers were used to grasp the catheter and cut it.Evidence of that is seen in flattened spines as well as in the wrinkled spine covers.The cuts are clean and under gross examination (without the help of any microscope) are indistinguishable from cut versus break.It could not be determined whether the nitinol spine that interacts with the shaft were cut during the intraoperative procedure or broke as a result of catheter failure.It couldn¿t be determined under gross examination whether the nitinol spine was still inside the distal tip of the shaft ( in the peek tubing) or not the tip of the sheath used to insert the catheter in the patient was intact.The catheter shaft itself was damaged most likely during the extraction procedure or during attempts to extract it.The soft tip is bent out of shape and the internal deflection mechanism has also been damaged as was evident when we tried to deflect the catheter and it deflected out of plane.Bwi could not further inspect pieces or dissect them.Since findings could not even determine if the catheter had indeed separated or it had been cut intra-operatively, bwi requested the hospital for intraoperative pictures.However, intraoperative pictures were not received from the hospital and it is unknown if any were taken by the surgeon during surgical extraction.Based on the investigation, it was confirmed that bwi did not find anything in the sample that clearly indicated a failure of the catheter and the root cause associated with this event remains unknown.All the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent this type of damage/defect from leaving the facility.

• Brand Name: LASSO NAV DUO LOOP ECO CATHETER
• Type of Device: ELECTRODE RECORDING CATHETER
• 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 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3898335
• MDR Text Key: 20017745
• Report Number: 9673241-2014-00236
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2015
• Device Model Number: D-1354-04-S
• Device Catalogue Number: D135404
• Device Lot Number: 16089506L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 190