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 Material Puncture/Hole (1504); Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2018

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.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.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a pentaray nav high-density mapping eco catheter, and during the procedure a 116 magnetic sensor error issue occurred.A second catheter was used to complete the operation.No adverse patient consequences were reported.The 116 magnetic sensor error issue has been assessed as not reportable.The device was returned to the bwi failure analysis lab (fal) on 9/11/2018 and on 9/27/2018 it was noted that one of the splines was deformed.The splines being described as deformed 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.On 9/27/2018 it was discovered that crushed rings were noticed on the catheter.One of the splines was deformed, and exposed metal was observed.In addition on 10/4/2018, a scanning electron microscope (sem) analysis showed evidence of mechanical damage, stress marks, and a hole with exposed wires on the surface of the spline spine cover.The surface of ring showed mechanical damage, scratches, and a sharp edge.It is possible that the damage was generated with an unknown object.The sharp edge on the electrode damage, the hole with exposed wires, and the damage observed on the catheter spline have has been assessed as reportable.The awareness date was reset to 9/27/2018.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a pentaray nav high-density mapping eco catheter, and during the procedure a 116 magnetic sensor error issue occurred.The investigational analysis completed on 11/12/2018.The device was inspected and one spine was found deformed.During a second visual inspection crushed rings and exposed metal was observed.The magnetic sensor functionality was tested on the carto and no errors were observed.However, some electrodes were observed black on the screen.Electrical testing was performed and the catheter failed.No electrical readings were observed on some electrodes.A failure analysis was performed and the catheter tip area was dissected.The electrical wire was found broken causing the improper electrical signal.Additionally, scanning electron microscope (sem) testing was performed on the damaged area and the results showed evidence of mechanical damage, stress marks, and a hole with exposed wires on the surface of the spine cover.The surface of the ring showed mechanical damage, scratches, and a sharp edge.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 the 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 not confirmed.The root cause of the damage observed on the lasso loop cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.The root cause of the electrical issue could be related to the damage on the loop.Manufacture reference no: (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: 8011072
• MDR Text Key: 126522562
• Report Number: 2029046-2018-02217
• 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: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2020
• Device Catalogue Number: D128211
• Device Lot Number: 17750811L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1