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 Manufacturing, Packaging or Shipping Problem (2975); Material Deformation (2976)

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

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device on 14-oct-2021.The device evaluation was completed on 16-dec-2021.The device was returned to biosense webster inc.(bwi) for evaluation.A visual inspection of the returned device was performed in accordance with bwi procedures.Visual analysis of the returned pentaray nav high-density mapping eco catheter revealed that a spline on the tip of the pentaray was damaged/elongated.Due to the conditions found, a manufacturing investigation was performed.The investigation concluded that the tip damage is non-manufacturing or packaging-related since several control inspections (visual and electrical inspections) were performed according to the appropriate procedures with acceptable results.In addition, the catheter was verified, and it was confirmed that it was used and connected to carto 3 system during the procedure.A manufacturing record evaluation was performed for the finished device 30586147l number, and no internal action was found during the review.It should be noted that product failure is multifactorial.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through bwi¿s quality system.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.(b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a premature ventricular contraction (pvc) procedure with a pentaray nav high-density mapping eco catheter and the biosense webster inc, (bwi) product analysis lab observed that a spline on the tip of the pentaray was damaged/elongated.Initially, it was reported that during a pvc procedure, the pentaray catheter spline was physically damaged out of the box.The catheter was replaced, and the issue resolved.No adverse patient consequences were reported.The out of box failure was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event is low.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found that a spline on the tip of pentaray catheter was damaged/elongated.This finding was assessed as mdr reportable.The awareness date for this reportable lab finding is 16-dec-2021.

• 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 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13227535
• MDR Text Key: 289679860
• Report Number: 2029046-2022-00079
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• 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: 30586147L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2021
• 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: UNKNOWN BRAND CATHETER