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

Catalog Number D128210

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2018

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) for the lot number 30062403l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.Concomitant product: carto 3 system, us catalog #: unknown, serial #: unknown.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) procedure with a pentaray nav high-density mapping eco catheter.It was reported that the pentaray nav high-density mapping eco catheter displayed an error 117 "eeprom error" when connected to the carto 3 system.The user noted this occurred when moving the catheter from 20b to 20a on the carto 3 patient interface unit (piu) before allowing the catheter to fully load on the carto 3 system.The cable was changed and the issue persisted.The catheter was changed and the issue resolved.This issue was assessed as not reportable.The user will not be able to use the device and will have to replace it.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The biosense webster failure analysis lab received the catheter for evaluation and discovered on october 2, 2018 that spline d was bent, electrode 16 was dented and the ring was slightly lifted.The bent spline was assessed as not reportable.If there¿s a light bent on the tip of the catheter; however, the integrity of the device is not compromised, and no wires are exposed; then the risk to the patient is remote.The slightly lifted electrode was assessed as reportable.Therefore, the awareness date has been assessed as october 2, 2018.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an ischemic ventricular tachycardia (isvt) procedure with a pentaray nav high-density mapping eco catheter.It was reported that the pentaray nav high-density mapping eco catheter displayed an error 117 "eeprom error" when connected to the carto 3 system.The user noted this occurred when moving the catheter from 20b to 20a on the carto 3 patient interface unit (piu) before allowing the catheter to fully load on the carto 3 system.The cable was changed and the issue persisted.The catheter was changed and the issue resolved.The device was inspected and the spline d was found bent and the electrode #16 was found dented, the ring was found slightly lifted.Then, the eeprom information was read and it was found corrupted.Then, the catheter outer diameter was measured and it was found within specification.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.On line, functional tests are in place to prevent this type of failure from leaving the facility.The customer complaint was confirmed.The root cause of the eeprom corrupted cannot be determined.The root cause of the electrode damage 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: 7991963
• MDR Text Key: 126231005
• Report Number: 2029046-2018-02193
• 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: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2021
• Device Catalogue Number: D128210
• Device Lot Number: 30062403L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Date Manufacturer Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1