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

Model Number D-1343-01-S

Device Problems Difficult to Remove (1528); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2015

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 (afib) procedure with a lasso navigational variable eco catheter.Initially they were unable to pull out the cable.Finally the cable could be pulled out but the catheter was not recognized when it was reconnected.The issue was resolved by changing the catheter.The procedure was completed without patient consequence.Both these issues were assessed as not reportable as the most likely consequence was an intraprocedural delay.The potential that they could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster failure analysis lab discovered on december 3, 2015 that the distal sides of rings #19 and #20 were dented and slightly lifted with white plastic like material stuck underneath the rings.The physician did not feel any resistance while removing the catheter.There was no information reported that this condition was observed upon removal of the catheter.The sheath used was not known.Dislodgement of the foreign material inside the patient poses a risk of embolus.The rings being lifted if sharp or rough may cause damage to vascular endothelial linings during the withdrawal of the catheter and sheath.Therefore, this returned catheter condition has been assessed as a reportable malfunction.The awareness date has been reset to december 3, 2015.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso navigational variable eco catheter.They were unable to pull out the cable.Finally the cable could be pulled out but the catheter was not recognized when it was reconnected.The issue was resolved by changing the catheter.The procedure was completed without patient consequence.Upon receipt, the catheter was visually inspected and the distal sides of rings #19 and #20 were found dented and slightly lifted with white plastic like material stuck underneath.A fourier transforms infrared spectroscopy (ft-ir) was performed in order to identify the type of foreign material under the rings.The results demonstrated that particle a was mainly composed of polyethylene (pe ) and a second compound corresponded to the barium sulfate a radiopacifier material widely used in the medical device industry; moving forward abs was identified a primary component for particle b.The catheter outer diameters were measured and it was found within specifications.The catheter was introduced in an instructions for use (ifu) recommended sheath and no resistance was noticed during this procedure.Further information received indicates that there was no resistance while introducing and removing the catheter.The catheter electrode condition was not noticed upon removing the catheter.The catheter was evaluated for eeprom, carto 3 and sensor functionality.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.No problem was noticed while connecting the catheter during the test.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 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: 5336708
• MDR Text Key: 35257752
• Report Number: 9673241-2015-00967
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/27/2015

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: 05/31/2018
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17268446L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2015
• 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