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

Model Number D-1282-11-S

Device Problem Noise, Audible (3273)

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

Event Date 03/18/2016

Event Type  malfunction  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) for the lot number 17318633l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4).

Event Description

It was reported that a patient underwent a procedure with two pentaray navigational eco catheters.During connection of the pentaray navigational catheter, there was noise on the surface ecg and the intracardiac (ic) signals.They were unable to see the major signal (pqrs wave).The issue was observed on all channels on both the carto system and the recording system.They were unable to monitor the patient's heart rhythm.Therefore, they disconnected the 20 pole cable from the patient interface unit (piu).The noise disappeared so they replaced the cable.However, the issue continued.Therefore, they replaced the catheter twice and the issue resolved.The procedure was completed with no patient consequence.Since the patient's heart rhythm was not visible to the operator, this event has been assessed as a reportable malfunction.Lack of monitoring of cardiac rhythm while devices are intracardiac might lead to undetected cardiac rhythm that can be life threatening.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 5/4/2016.Additional clarification was received on 5/4/2016 that the lot # was corrected from 17318633l to 17359160l.Therefore, the product information has been corrected to the manufacturer date of 11/7/2015 and the expiration date of 10/31/2018.The investigational analysis has been completed.(b)(4).It was reported that a patient underwent a procedure with two pentaray navigational eco catheters.During connection of the pentaray navigational catheter, there was noise on the surface ecg and the intracardiac (ic) signals.They were unable to see the major signal (pqrs wave).The issue was observed on all channels on both the carto system and the recording system.They were unable to monitor the patient¿s heart rhythm.Therefore, they disconnected the 20 pole cable from the patient interface unit (piu).The noise disappeared so they replaced the cable.However, the issue continued.Therefore, they replaced the catheter twice and the issue resolved.The procedure was completed with no patient consequence.The returned device was visually inspected upon receipt and it was found in normal conditions.Per the event, 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 customer complaint cannot be confirmed.

• Brand Name: PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 5568311
• MDR Text Key: 43031550
• Report Number: 9673241-2016-00259
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: D-1282-11-S
• Device Catalogue Number: D128211
• Device Lot Number: 17318633L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2015
• 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