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

Model Number D128211

Device Problems Signal Artifact/Noise (1036); Material Too Rigid or Stiff (1544); Contamination /Decontamination Problem (2895); Sharp Edges (4013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2021

Event Type  malfunction  

Event Description

It was reported that a patient underwent a procedure with a pentaray nav high-density mapping eco catheter, and the biosense webster, inc.Product analysis lab observed ¿electrode damage¿ and ¿foreign particle in electrode¿ issues.Initially it was reported that during the procedure, the electrical potentials (electrode) 13,15 displayed black on the carto 3 screen, a signal noise occurred at the electrical potentials 13-14 and 15-16 too on both the carto 3 and the lab.This issue occurred after 1 to 2 hours since the catheter was used.Furthermore, the physician stated that the steering wheel was slightly harder than usual.The issue occurred right after opened.The issue was resolved by changing the catheter.The procedure was successfully completed without patient consequence.The sheath information is not known.There was no damage for the pentaray nav high-density mapping eco catheter.The signal issue on the catheter was assessed as not mdr reportable.The risk to the patient was low.The issue reported as the steering wheel was slightly harder than usual was assessed as not reportable for catheter stiffness deflection mechanism.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 07-mar-2022 the electrodes on spline b were damaged and a white fiber was found attached to one of the electrodes.The returned condition was assessed as mdr reportable for both ¿electrode damage¿ and ¿foreign particle in electrode¿.The awareness date for this reportable lab finding was 07-mar-2022.

Manufacturer Narrative

Initial reporter phone: (b)(6).The bwi product analysis lab received the device for evaluation on 13-jan-2022.The device evaluation was completed on 07-mar-2022.The device was returned to biosense webster for evaluation.A visual inspection, deflection, and electrical tests of the returned device were performed in accordance with biosense webster, inc.Procedures.Visual analysis of the returned pentaray nav eco device revealed that the electrodes on spline b were damaged and a white fiber was found attached to one of the electrodes.An electrical test was performed and open circuits were found on the damaged electrodes.A deflection test was performed and the device passed the test within specification.No stiffness was felt during the test.A comparison was made to another unit sample and no anomalies were detected.An fourier transform infrared spectroscopy (ftir) analysis was performed to determine the composition of the white fiber and the results showed that the material was mostly composed of abs (acrylonitrile butadiene styrene) which could belong to another device used during the procedure.The source of the damage to the electrodes remains unknown as there¿s not enough information to reach a definitive conclusion but it was theorized that a sudden movement and use of incompatible devices along with this complaint unit could be related to the damage, which later caused the electrical issues observed by the customer.The electrical issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use contain the following recommendations: ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient; to resolve this situation, verify the proper connection.A manufacturing record evaluation was performed for the finished device 30635803l number, and no internal actions related to the reported complaint condition were identified.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.(b)(4).Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on 01-apr-2022 confirming that there was no damage noted for the pentaray nav high-density mapping eco catheter.Additional information was received on 18-apr-2022.The navigo sheath and sl sheath were used during the procedure.Therefore, updated the d10.Concomitant medical products and therapy dates section to include these sheaths and removed unknown brand sheath.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 13973951
• MDR Text Key: 290528884
• Report Number: 2029046-2022-00694
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30635803L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 04/01/2022
• Supplement Dates FDA Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: JPN CARTO 3 SYSTEM; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER; UNKNOWN BRAND NAVIGO SHEATH; UNKNOWN BRAND SHEATH; UNKNOWN BRAND SL SHEATH