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 Material Separation (1562); Material Protrusion/Extrusion (2979); Separation Problem (4043)

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

Event Date 04/18/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a procedure with a pentaray nav high-density mapping eco catheter.Device damaged.During the procedure, the device was found damaged.A picture was provided.A second device was used to complete the procedure.There was no adverse event reported on patient.Additional information was received.The damage resulted in wires being exposed.The damage did not result in any lifted or sharp rings.No resistance or difficulty during insertion or removal of the catheter.It was not known if the catheter was pre-shaped.The event was assessed as mdr reportable for internal components exposed.

Manufacturer Narrative

The picture investigation was completed on (b)(6) 2023.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the shaft was observed broken at the tip transition, exposed parts were observed.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) in the 3500a initial, it was assessed as mdr reportable for internal components exposed and the h6.Medical device problem code¿s reported were processed as material separation (a0413) and material protrusion / extrusion (a0411).During an internal review on 17-may-2023, the event was reassessed to mdr reportable for a catheter partially separated issue.Therefore, corrected the h6.Medical device problem code to reflect only as a separation problem (a1503).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 19-may-2023.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a procedure with a pentaray nav high-density mapping eco catheter.Device damaged.During the procedure, the device was found damaged.A second device was used to complete the procedure.There was no adverse event reported on patient.Additional information was received.The damage resulted in wires being exposed.The damage did not result in any lifted or sharp rings.No resistance or difficulty during insertion or removal of the catheter.It was not known if the catheter was pre-shaped.The device evaluation was completed on 24-may-2023.The product was returned to biosense webster (bwi) for evaluation.A visual inspection was performed following bwi procedures.According to pictures provided by the customer, the shaft was observed broken at the tip transition, exposed parts were observed.Visual analysis in the lab revealed that the catheter shaft was observed detached from its original place, leaving internal components exposed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).During an internal review on 16-jun-2023, noted a correction to the 3500a initial.Removed code h6.Component code of tip (g04129).The correct code is rod/shaft (g04112).Therefore, updated this field accordingly.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16943480
• MDR Text Key: 316010962
• Report Number: 2029046-2023-01044
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/16/2023

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: 31000598L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: 05/17/2023; 05/19/2023; 05/24/2023
• Supplement Dates FDA Received: 05/18/2023; 05/22/2023; 06/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2023
• 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.