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 Problem Device Displays Incorrect Message (2591)

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

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 12/30/15.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 device history record (dhr) for the lot number 17333454l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4).

Event Description

This complaint is originally created for an mdr non-reportable issues.It was reported that a lasso catheter sensor error was displayed on the carto 3 system and points could not be taken.The issue was not resolved by changing the catheter cable.The catheter was not replaced and the case was continued.This complaint was re-assessed to mdr reportable per bwi failure analysis lab findings on 12/30/2015.Ring #1 was squashed and proximal side was sharp and folded over.Proximal side of ring #14 was sharp and folded over.This is mdr reportable as sharp rings posed risk to the patient and caused the potential of vasculature and cardiac injury.The awareness date of this complaint is reset to 12/30/2015 based on lab findings on 12/30/2015.

Manufacturer Narrative

(b)(4).It was reported that a catheter sensor error was displayed on the carto 3 system and points could not be taken.The catheter cable was replaced and the issue remained.The catheter was not replaced and the case was continued.The returned device was visually inspected upon receipt and ring #1 and ring #14 were found squashed folded over and sharp.The catheter outer diameters were measured and it was found within specifications.Catheter was introduced in an ifu recommended sheath and no resistance was noticed during this procedure.Further information received indicates that the electrode damage was found while removing the catheter; and that 7.5 french sheath was used during the procedure.The ifu indicates that an 8 french sheath is recommended, this might contributed to the electrode damage.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.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: 5375522
• MDR Text Key: 36637948
• Report Number: 9673241-2016-00041
• 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
• Report Date: 12/08/2015

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: 09/30/2018
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17333454L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 01/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1