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 Break (1069); Material Twisted/Bent (2981); Mechanical Jam (2983); Torn Material (3024)

Patient Problem Tissue Damage (2104)

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a lasso navigational variable eco catheter.During the fast anatomical mapping in the left atrium, the catheter got stuck in the mitral valve.It took at least 6-7 minutes to remove it.They then saw some red tissue on it and the catheter was damaged between the loop and the shaft.There was no wires exposed.There were no lifted or sharp rings.The catheter was not pre-shaped.The 8f preface sheath was used.The patient did not have any symptoms but they were going to examine him further within the next hour.They lost approximately 15 minutes from the procedure.At the end, the patient was successfully ablated.The procedure was completed with no patient consequence.These issues were assessed as not reportable as they do not pose any risk to the patient.The tissue was present and noted during the procedure but the patient was free of symptoms or distress of any kind.The device was also removed without surgical intervention.Also per the additional information received, there were no wires exposed or lifted or sharp rings.Therefore, with the information available at the time, the catheter integrity was maintained.The biosense webster failure analysis lab received the catheter for analysis on july 6, 2016 and discovered that the spine was twisted, the outer cover of the catheter was torn and internal parts were exposed.Therefore, since the catheter integrity has been compromised, this returned catheter condition of the internal parts exposed has been assessed a reportable malfunction.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a lasso navigational variable eco catheter.During the fast anatomical mapping in the left atrium, the catheter got stuck in the mitral valve.It took at least 6-7 minutes to remove it.They then saw some red tissue on it and the catheter was damaged between the loop and the shaft.There was no wires exposed.There were no lifted or sharp rings.The catheter was not pre-shaped.The 8f preface sheath was used.The patient did not have any symptoms but they were going to examine him further within the next hour.They lost approximately 15 minutes from the procedure.At the end, the patient was successfully ablated.The procedure was completed with no patient consequence.Upon receipt, the catheter was visually inspected and the spine was found twisted near the loop with internal parts exposed.The catheter outer diameters were measured and they were found within specifications.According to the event description lasso got stuck at the mitral valve and it took 6-7 minutes to be released; the catheter loop damages observed might be related to the efforts to disengage the catheter from the mitral valve.The instructions for use (ifu) states that in order to prevent entanglement of the catheter with the valves, care should be taken around the atrio-ventricular valve region.It is also stated that careful manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.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.The customer complaint has been verified.Based on available analysis results, the failure mode does not appear to be caused by any internal biosense webster, inc.Processes.The instructions for use (ifu) states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

• 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: 5819013
• MDR Text Key: 51232407
• Report Number: 9673241-2016-00452
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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,Followup
• Report Date: 06/14/2016

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: 03/31/2019
• Device Model Number: D-1343-02-S
• Device Catalogue Number: D134302
• Device Lot Number: 17442012L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 07/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2016
• 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