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

Catalog Number D128208

Device Problems Entrapment of Device (1212); Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2018

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.The device history record (dhr) for the lot number 17758398l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Concomitant product: 1.Carto 3, us catalog #: fg540000m, serial #: (b)(4).Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for ventricular tachycardia with a pentaray nav high-density mapping eco catheter.While mapping the left ventricle with the pentaray nav high-density mapping eco catheter, the deflection mechanism broke and was stuck in the deflected position.Physician was unable to relax the deflection.The pentaray nav high-density mapping eco catheter was removed under x-ray guidance.The procedure was completed with no patient consequence.The medical device entrapment issue was assessed as not reportable.The device was able to be removed without surgical intervention.The potential risk that it could cause or contribute to a serious injury or death to the patient was remote.The catheter being stuck in a deflected position was assessed as a reportable malfunction.

Manufacturer Narrative

Additional information was received on the event on (b)(6) 2018.It was confirmed that the curve of the catheter was stuck in a fully deflected position.The piston was unable to be pushed up and down.There was difficulty in removing the catheter.There was no obvious physical damage observed at the distal end of the catheter.There was no sheath used.There were no pictures available.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

The biosense webster inc.Failure analysis lab received the device for evaluation on 3/1/2018.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.No: (b)(4).

Manufacturer Narrative

During additional assessment on (b)(6) 2018 by the biosense webster, inc.Failure analysis lab, it was discovered that ¿some spines of the catheter were slightly bent¿.This issue has been assessed as not reportable.If at least one of the spines of the catheter is bent; however it¿s not broken or detached, then the potential risk that it could cause or contribute to a death or serious injury was remote.Investigation summary: it was reported that a patient underwent an ablation procedure for ventricular tachycardia with a pentaray nav high-density mapping eco catheter.There was no sheath used.While mapping the left ventricle with the pentaray nav high-density mapping eco catheter, the deflection mechanism broke and was stuck in a fully deflected position.The piston was unable to be pushed up and down.Physician was unable to relax the deflection.There was difficulty in removing the catheter.The pentaray nav high-density mapping eco catheter was removed under x-ray guidance.There was no obvious physical damage observed at the distal end of the catheter.The procedure was completed with no patient consequence.The device was visually inspected and it was found in normal conditions; however, during the second visual inspection some spines were found slightly bent.Then per the event, a deflection test was performed and the catheter passed.Then, the catheter 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 spines condition cannot be determined since there is evidence that device was manufactured in accordance with documented specification and procedures, it could be related to the manipulation of the device during the procedure.Manufacturer's reference number: (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: 7286065
• MDR Text Key: 100897058
• Report Number: 2029046-2018-01230
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: 10846835012224
• 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,Followup,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Catalogue Number: D128208
• Device Lot Number: 17758398L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Date Manufacturer Received: 01/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1