MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) DECANAV¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number D-1285-01-S

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Complete Heart Block (2627)

Event Date 05/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The returned device was visually inspected upon receipt and it was found in normal conditions.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 catheter was tested for electrical performance and it was found 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.The catheter passed all specifications.The root cause of the heart block could not be conclusively determined.However, neither the analysis nor the dhr suggest that the failure reported could not be related to the manufacturing process.

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto 3 system and suffered a heart block requiring cardiac massage.During the procedure, when the decanav¿ electrophysiology catheter was connected to the 20 pole a socket, a leakage error occurred.Subsequently, all channels connected to the carto 3 system displayed ¿n/a¿.Physician was unable to pace through catheters connected to the carto 3 system.Signal loss was observed on all ecg channels on the carto 3 system.Body surface ecg signal was available for the physician to monitor the cardiac rhythm.Pacing was planned.Pacing leads were connected to the primary pacing port.Carto did not allow pacing and ablating at the same time.Pacing stimulator manufacturer was fukuda denshi.This event was originally assessed as not mdr reportable because the potential that these issues could cause or contribute to a death, serious injury, or other significant adverse event is remote.On february 1, 2017 additional information was received that while troubleshooting for the issue above with the catheter in the cardiac cavity, an atrioventricular block (av) occurred.Since the carto was unable to pace, emergency cardiac massage was performed, which resolved the av block.Carto cable was changed and the system issue resolved.There is no information regarding extended hospitalization.Patient fully recovered.It was noted that the catheter shaft likely bumped the av node.It was noted that although there was no relationship between the av block and the carto 3 system issue, treatment for the av block was delayed.Physician¿s opinion regarding the cause of the adverse event is that it was related to a bwi product malfunction and procedure.The awareness date was reset to february 1, 2017, because that is when information was received that there was an injury during trouble shooting.

• Brand Name: DECANAV¿ ELECTROPHYSIOLOGY 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 ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6360670
• MDR Text Key: 68406528
• Report Number: 9673241-2017-00143
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080425
• 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
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: D-1285-01-S
• Device Catalogue Number: R7D282CT
• Device Lot Number: 17388265M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/17/2016
• Initial Date FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2016
• 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
• Patient Outcome(s): Required Intervention