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 Problem Device Alarm System (1012)

Patient Problem No Code Available (3191)

Event Date 02/11/2016

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 17371097l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.Concomitant medical products: carto 13432, stockert g4c-0238, and g4cp-0254.Us catheter 10439236 serial number (b)(4).(b)(4).

Event Description

It was reported that a female patient underwent an ablation procedure for afib.And a 4 mm clot was seen about 15mm down the shaft after trans-septal puncture when the lasso nav variable eco catheter was advanced into the left atrium.The sheath was in the right atrium.No ablation was done and case was aborted.The system did not present any error messages.Patient was under general anesthesia.Patient was heparinized for procedure based on routine protocol.Initial neurological exam seems normal.The clot disappeared and it was not known where it is.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 03/03/2016.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.

Manufacturer Narrative

(b)(4).It is reported that after transeptal the lasso was advanced.The sheath was in the right atrium and the lasso was in the left atrium.Through us a 4 mm clot was seen where the loop meets the shaft about 15mm down the shaft.No ablation was done and case was aborted.Initial neurological exam seems normal.The clot disappeared and it is not known where it is.Upon receipt, the catheter was visually inspected and it was found in normal conditions.Per the event, the catheter was tested for electrical performance and it was found within specifications.Furthermore, an irrigation test was performed and the catheter passed, no occlusion was observed.A deflection test was performed and the catheter passed.The catheter was also evaluated for carto 3.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.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 catheter passed all specifications.The root cause of the tamponed remains unknown.The ifu states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponed.Customer complaint cannot be confirmed.

• 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 ; 9497893837
• MDR Report Key: 5462000
• MDR Text Key: 39090098
• Report Number: 9673241-2016-00133
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: D-1343-02-S
• Device Catalogue Number: D134302
• Device Lot Number: 17371097L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/11/2016
• Initial Date FDA Received: 02/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/10/2016; 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other