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

Catalog Number D128210

Device Problems Bent (1059); Hole In Material (1293); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2017

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.The device history record (dhr) for the lot number 17710257l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.(b)(4).

Event Description

It was reported that a patient underwent an atrial flutter (afl) procedure with a pentaray nav high-density mapping eco catheter.It was originally reported that when they advanced the pentaray nav high-density mapping eco catheter through the sheath, one of splines became bent/kinked.Changing the catheter resolved the issue.There were no patient consequences reported.The additional information clarified that the damage did not result in wires being exposed and no lifted or sharp rings.There was resistance or difficulty during insertion or removal of this catheter.The catheter was not pre-shaped.A cordis sheath was used.The resistance with sheath was assessed as not reportable.Interference or friction between devices is a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.This is a common practice during procedures.Since the vast majority of ep procedures utilize multiple device exchanges, an increased potential for patient injury was remote.The benk/kinked spline was assessed as not reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster failure analysis lab received the device for evaluation and on (b)(6) 2018 during assessment it was found that the electrode rings were crushed and had sharp edges.On (b)(6) 2018 during the scanning electron microscope (sem) analysis, it showed that there was evidence of mechanical damage, scratches and an opening on the surface of the electrode; however no sharp edges were observed.After reviewing the picture taken of the product issue which was attached on (b)(6) 2018, it showed the catheter electrode was squashed and lifted.The sem analysis confirmed that there were no sharp edges; however, it also confirms that the electrode was damaged and there was an opening observed on the surface.Therefore, the electrode ring being lifted with the device integrity not maintained, was assessed as a reportable malfunction.The awareness date for this issue was (b)(6) 2018.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an atrial flutter (afl) procedure with a pentaray nav high-density mapping eco catheter.It was originally reported that when they advanced the pentaray nav high-density mapping eco catheter through the sheath, one of splines became bent/kinked.Changing the catheter resolved the issue.There were no patient consequences reported.The additional information clarified that the damage did not result in wires being exposed and no lifted or sharp rings.There was resistance or difficulty during insertion or removal of this catheter.The catheter was not pre-shaped.A cordis sheath was used.The returned device was visually inspected and rings were found crushed.Then, the catheter outer diameter was measured and it was found within specification.Additionally, a scanning electron microscope (sem) testing was performed on the damage area and the results showed evidence of mechanical damage, scratches and an opening on the surface of the electrode, however no sharp edges were observed.It is possible that the damage was generated with an unknown object.No other anomalies were 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.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 was confirmed.The root cause of the damage on electrodes cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.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: 7550060
• MDR Text Key: 110045539
• Report Number: 2029046-2018-01597
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012248
• UDI-Public: 10846835012248
• 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: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: D128210
• Device Lot Number: 17710257L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Date Manufacturer Received: 05/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1