MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number D128211

Device Problems Failure to Read Input Signal (1581); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2017

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 pentaray nav high-density mapping eco catheter and the catheter had noise/interference.The catheter was changed and the issue resolved.The procedure was completed with no patient consequence.This event was originally assessed as not mdr reportable because the risk to the patient is low.The device was returned to the biosense webster failure analysis lab for analysis on (b)(6) 2017 and during visual inspection it was discovered that one of the electrodes was squashed and a sharp edge was formed.This finding is mdr reportable because electrode ring edges that appear to be sharp or rough, may potentially cause patient injury.The awareness date has been reset to (b)(6) 2017, the date the reportable finding was discovered.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a pentaray nav high-density mapping eco catheter and the catheter had noise/interference.The returned device was visually inspected and one electrode was found squashed with a sharp edge, which made this complaint mdr reportable.Per the event, the catheter was tested for electrical performance and it was found within specifications.Then, the outer diameter was measured 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.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 cannot be confirmed.The root cause of the damage observed could be related to the handling of the product since there is evidence that the device was manufactured in accordance with documented specification and procedures.(b)(4).

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 7129551
• MDR Text Key: 95932736
• Report Number: 2029046-2017-01283
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: (01)10846835012255(11)170511(17)200430(10)17665532L
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123837
• 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: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: D128211
• Device Lot Number: 17665532L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1