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); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2014

Event Type  malfunction  

Event Description

It was reported that a patient, underwent an atrial fibrillation (afib) procedure with a lasso navigational variable eco catheter.The physician felt difficulties removing the lasso navigational variable eco catheter from the sl1 sheath at the beginning of the procedure during initial mapping when they were going to do an angiography.The catheter was visually inspected and unspecific material was identified on the tip surrounding the atraumatic ball tip.No complications were reported regarding this complaint.The catheter was replaced with a new catheter and the procedure continued normally.The procedure was completed successfully with a similar-like device and no patient consequence.Additional clarification was requested on the event, however, no further information was made available.With the information available, this complaint was not reportable.Upon visual inspection of the returned complaint catheter on (b)(4) 2014, the bwi failure analysis lab noted foreign material on the pu ball tip.The spine cover was twisted from the proximal side of electrode ring #20 to pu joint with peek housing.This event was originally considered non reportable, however, bwi confirmed that there was foreign material on the pu ball tip and have reassessed the event as reportable.The awareness date is (b)(6) 2014.

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.The reported lot number is 16047536l.Concomitant products: 1.Carto 3 system: model #: unknown, serial #: unknown.2.Navistar st df catheter: model #: unknown, lot #: unknown.(b)(4).

Manufacturer Narrative

(b)(4) it was reported that a patient, underwent an atrial fibrillation (afib) procedure with a lasso navigational variable eco catheter.The physician felt difficulties removing the lasso navigational variable eco catheter from the sl1 sheath at the beginning of the procedure during initial mapping when they were going to do an angiography.The catheter was visually inspected and unspecific material was identified on the tip surrounding the atraumatic ball tip.No complications were reported regarding this complaint.The catheter was replaced with a new catheter and the procedure continued normally.The procedure was completed successfully with a similar-like device and no patient consequence.Upon receipt, the catheter was visually inspected and there was a foreign material around the pu ball tip.In addition the spine cover was twisted from the proximal side of ring 20.A ft-ir test was performed in order to identify the type of foreign material; the results demonstrated that the material had a biological composition similar to that observed in human and biological tissues.However, it remains unknown the origin of it.In addition, the catheter outer diameters were measured and catheter was within specifications.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.All the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent foreign material leaving the facility.The reported customer complaint regarding the unspecific material has been verified.

• 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 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3960797
• MDR Text Key: 4606389
• Report Number: 9673241-2014-00281
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: UNKNOWN_D-1343-01-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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