MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Catalog Number NS7TCDL174HS

Device Problems Hole In Material (1293); Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2017

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.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.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a navistar¿ electrophysiology catheter and the catheter could not be recognized.The catheter was changed to another one and the issue resolved.The procedure was completed without patient consequence.This event was originally assessed as not mdr reportable because the potential risk that it could cause or contribute to a serious injury or death is remote.The device was returned to the biosense webster failure analysis lab and on (b)(6) 2018, reddish material was observed inside the tip lumen and an abnormality was observed on the peek/dome.Scanning electron microscope analysis was not possible due to the complexity of the area to analyze (dome/peek).Therefore, the analysis was done on the microscope and damage was observed where the polyurethane bonds the peek housing and the dome.A hole was observed in this area and could be the contributor to allow the access of the reddish material to the lumen of the tip.This finding has been assessed as a reportable malfunction.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a navistar¿ electrophysiology catheter and the catheter could not be recognized.The returned device was visually inspected and it was found in normal conditions.The catheter was evaluated for eeprom.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.Sensor catheter functionality was tested on carto system.The carto 3 system recognized the catheter.However, magnetic sensor error 105 was displayed.The catheter was then dissected and reddish material was found.Then it was determined that the root cause was an internal failure of the sensor.The reddish material found within the catheter prompted further investigation.After further investigation, a hole was observed on the catheter tip.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.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint was confirmed.The root cause of the damage on the tip cannot be determined.It could be related to the manipulation of the device.(b)(4).

• Brand Name: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 7398178
• MDR Text Key: 104735684
• Report Number: 2029046-2018-01409
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835000597
• UDI-Public: 10846835000597
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P990025
• 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: 03/15/2018

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: 05/31/2020
• Device Catalogue Number: NS7TCDL174HS
• Device Lot Number: 17688330M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 04/04/2018
• Supplement Dates Manufacturer Received: 03/15/2018
• Supplement Dates FDA Received: 05/09/2018
• Date Device Manufactured: 06/20/2017
• 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