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

Model Number D-1312-01-S

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2015

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 procedure with a lasso nav catheter and a mapping issue occurred as the catheter could not build the model.The catheter was changed to another one and the procedure was completed with no patient consequence.This event was originally assessed as not reportable as the potential risk that it could cause or contribute to a serious injury or death is remote.Biosense webster failure analysis lab received the device for evaluation on september 2, 2015 and during visual inspection it was discovered that ring #1 and ring #4 are lifted /pulled back causing sharp edges.Upon request additional information was received on the returned catheter condition.There was no difficulty withdrawing the catheter from the patient that may have caused this damage.The returned catheter condition was not noticed prior to use of the catheter, upon withdrawal or prior to sending the catheter back for analysis.This finding is indicative of a reportable event because the sharp edges could potentially harm the patient.The awareness date for this record is september 2, 2015 because that is when the product was received.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a lasso nav catheter and a mapping issue occurred as the catheter could not build the model.Upon receipt, the catheter was visually inspected and ring #1 and #4 were found lifted and sharp which is why this complaint was reported to the fda.Per these conditions, the catheter outer diameters were measured and it was found within specifications.Catheter was introduced in instructions for use recommended sheath and no resistance was noticed during this procedure.Further information received indicates that this condition was not noticed prior to sending the catheter back.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.Per the event reported the catheter was evaluated for eeprom, and the functionality of the sensor catheter was tested on carto system.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was recognized by carto 3 system, however error 116 was displayed.The catheter was then dissected and it was determined that the root cause was an internal failure of the sensor.The customer complaint has been confirmed.The root cause of the sensor breakage could not be determined.

• Brand Name: LASSO® NAV 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: 5102504
• MDR Text Key: 26835132
• Report Number: 9673241-2015-00679
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K093376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/05/2015

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: 08/31/2015
• Device Model Number: D-1312-01-S
• Device Catalogue Number: DLN1215CT
• Device Lot Number: 17086091L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2014
• 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