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 Break (1069); Device-Device Incompatibility (2919)

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

Event Date 12/06/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a pentaray nav high-density mapping eco catheter and a broken tip issue occurred.It was reported that after using the catheter for ten minutes, right after insertion into the patient¿s body, the catheter was removed twice when it was moved in and out from the sheath.As the spine became loose, and the catheter could not enter through the port of the sheath, the catheter was replaced.The procedure was completed without patient's consequence.The broken tip issue is mdr reportable.

Manufacturer Narrative

Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The device evaluation was completed on 23-feb-2023.It was reported that a patient underwent a cardiac ablation procedure with a pentaray nav high-density mapping eco catheter and a broken tip issue occurred.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.No issues were found.A manufacturing record evaluation was performed for the finished device 30867030l number, and no internal actions related to the reported complaint condition were identified.The mechanical issue reported by the costumer could not be confirmed.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).

Manufacturer Narrative

On 05-jan-2023, the biosense webster, inc.Product 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.Additional event information was received on 12-jan-2023.It was reported that the damage did not result in wires being exposed.The damage did not result in any lifted or sharp rings.There was resistance or difficulty during insertion or removal of the catheter when trying to put in with the dilator.Therefore, the h 6.Medical device problem code was updated.It was reported that there is no picture available.Additional information was received on 26-jan-2023.The catheter was not pre-shaped.The sheath used was a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.Therefore, the concomitant product section was updated.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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16093130
• MDR Text Key: 307894800
• Report Number: 2029046-2023-00019
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2023

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: 30867030L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 01/05/2023; 02/23/2023
• Supplement Dates FDA Received: 02/02/2023; 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2022
• 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: 8.5F SHEATH WITH CURVE VIZ MDC.; PENTARAY NAV ECO 7FR, D, 2-6-2.; PENTARAY NAV ECO 7FR, D, 2-6-2.; UNK BRAND CABLE.; UNK BRAND CABLE.