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 Device Contamination with Chemical or Other Material (2944); Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2018

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.Manufacturer's ref.# (b)(4).

Event Description

It was reported a patient underwent a paroxysmal atrial fibrillation with a procedure with a pentaray nav high-density mapping eco catheter and a catheter sensor error occurred.It was reported the patient was prepared in the usual fashion.The pentaray nav high-density mapping eco catheter was connected and placed in the right atrium.When connected, error 116, ¿catheter sensor error¿ appeared on the carto 3 system.Attempts to resolve the issue included disconnecting and reconnecting the catheter cable and ultimately replacing the catheter.When the catheter was replaced, the error no longer appeared on the carto 3 system.The case continued without further issues.No patient consequence was reported.On 1/7/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis identified, ¿spine c is bent approximately 1.5 cm from distal end of pu dome.All rings have been squashed down.All rings have been squashed down.Ring #11 has some type of white plastic like material underneath the ring stick out on the proximal side.¿ the findings of the ring damage and the foreign material have been assessed as mdr reportable malfunctions.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction on 1/7/2019 and reassessed this complaint as reportable.

Manufacturer Narrative

It was reported the patient was prepared in the usual fashion.The pentaray nav high-density mapping eco catheter was connected and placed in the right atrium.When connected, error 116, ¿catheter sensor error¿ appeared on the carto 3 system.Attempts to resolve the issue included disconnecting and reconnecting the catheter cable and ultimately replacing the catheter.When the catheter was replaced, the error no longer appeared on the carto 3 system.The case continued without further issues.No patient consequence was reported.On 1/7/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis identified, ¿spine c is bent approximately 1.5 cm from distal end of pu dome.All rings have been squashed down.Ring #11 has some type of white plastic like material underneath the ring stick out on the proximal side.¿ the findings of the ring damage and the foreign material have been assessed as mdr reportable malfunctions.Device evaluation details: on 1/31/2019, 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 failure from leaving the facility.On 2/7/2019, the device evaluation was been completed.The device was inspected and the spine c was found bent and the rings were observed squashed.Ring # 11 was found with some type of white plastic underneath the ring.During the second visual inspection, the material was not observed, it could be lost during the handling of the device.The magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, the catheter¿s outer diameter was measured and it was found within specification.The customer complaint cannot be confirmed.The root cause of the damage cannot be determined, it could be related to the procedure and the friction with the sheath, however this cannot be conclusively determined.In addition, there is evidence that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s ref # (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
• MDR Report Key: 8280397
• MDR Text Key: 136186990
• Report Number: 2029046-2019-02605
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2021
• Device Catalogue Number: D128211
• Device Lot Number: 30092884L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1