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); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2019

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.A manufacturing record evaluation was performed for the finished device 30184161l number, and no internal action was found during the review.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter that had internal wires showing upon retraction from patient¿s body.It was reported that at the end of the case, when the pentaray nav high-density mapping eco catheter was pulled out of the patient¿s body it had a spline that was showing some wires and had an unconventional shape.There was no patient consequence reported.On 6/4/2019, additional information about the event was received indicating the damage did not result in any lifted or sharp rings.There was no known resistance during insertion or removal of the pentaray nav high-density mapping eco catheter.Issue found at distal electrode and the catheter shape was not assessed prior to insertion.Unsure what sheath was used.The customer¿s reported issue of internal components being exposed has been assessed as an mdr reportable malfunction.On 6/13/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual inspection found what appeared to be ¿fibers stuck / protruding from the electrode just below the dome of one of the splines.The 3rd & 4th electrode on the same spline look compressed / flattened.¿ the returned conditions have been reviewed and assessed as mdr reportable for the foreign material of ¿fibers¿.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter that had internal wires showing upon retraction from patient¿s body.It was reported that at the end of the case, when the pentaray nav high-density mapping eco catheter was pulled out of the patient¿s body it had a spline that was showing some wires and had an unconventional shape.There was no patient consequence reported.Device evaluation details: the device evaluation has been completed.The device was inspected and some fibers were observed stuck/protunding from the electrode in one spline and some electrodes were observed flattened and compressed.During the second visual inspection, one spline was observed bent and damaged, some electrodes were observed squashed and two electrodes were observed with foreign material and with lifted borders.After that, the outer diameter was measured, and it was found within specifications.A fourier transform infrared spectroscopy test (ftir) was performed and the results showed that white particle is composed of acrylonitrile butadiene styrene (abs) base material while the translucent foreign material showed the absorption bands for polytetrafluoroethylene (ptfe)-based material.The source of origin for both particles remains unknown.The visual findings and the ftir analysis findings were reviewed and continue to be assessed as mdr reportable malfunctions.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the damage observed on the spline, the electrodes and foreign material cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.The foreign material observed could be generated due to the manipulation of the catheter with the sheath since a damage electrode was observed.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: 8737168
• MDR Text Key: 150166133
• Report Number: 2029046-2019-03331
• 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
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2022
• Device Catalogue Number: D128211
• Device Lot Number: 30184161L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Date Manufacturer Received: 07/23/2019
• Patient Sequence Number: 1