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 Device Displays Incorrect Message (2591)

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

Event Date 03/11/2016

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) 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 atrial fibrillation procedure with a pentaray nav eco high-density mapping catheter and a clot was observed on the catheter.An alarm on the infusion pump for irrigation was heard during the mapping phase.The catheter was removed from the cardiac cavity and a clot, possibly coagulum, was found on the catheter.The issue was resolved by changing the catheter to another one.The procedure was completed without patient consequence.Anticoagulant was used during the procedure.Settings during the event include: power control mode with an irrigation flow of 40 ml/h.This event is mdr reportable because the presence of a clot or coagulum has the potential to cause patient harm.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 04/15/2016.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.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a pentaray nav eco high-density mapping catheter and a clot was observed on the catheter.An alarm on the infusion pump for irrigation was heard during the mapping phase.The catheter was removed from the cardiac cavity and a clot, possibly coagulum, was found on the catheter.Upon receipt, the catheter was visually inspected and it was found in normal conditions.No coagulum was observed on catheter tip.An irrigation test was performed and the catheter passed, no occlusion was observed.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 regarding a coagulum and a catheter occlusion 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: 5548286
• MDR Text Key: 42526002
• Report Number: 9673241-2016-00221
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 03/14/2016

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-1282-11-S
• Device Catalogue Number: D128211
• Device Lot Number: 17356120L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/05/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/02/2016; 05/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2015
• 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