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

Model Number D128211

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/01/2021

Event Type  malfunction  

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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a pentaray nav high-density mapping eco catheter and a tip fully separated issue occurred.It was reported that the electrode is broken.The damage did not result in wires and/or braid being exposed or any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the device.One of the electrode is broken, ¿catheter looks no problem¿.There was one detachment, ¿when catheter into sheath will remove detachment¿.The part of the device that was detached is the spin part.The catheter was not pre-shaped.There was no patient consequence.

Manufacturer Narrative

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.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

The device evaluation was completed on (b)(6)-2022.It was reported that a patient underwent a cardiac ablation procedure with a pentaray nav high-density mapping eco catheter and a tip fully separated issue occurred.It was reported that the electrode is broken.The damage did not result in wires and/or braid being exposed or any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the device.One of the electrode is broken, ¿catheter looks no problem¿.There was one detachment, ¿when catheter into sheath will remove detachment¿.The part of the device that was detached is the spin part.The catheter was not pre-shaped.There was no patient consequence.Device evaluation details: 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 some electrodes were bent and with polyurethane (pu) covering the edges, however, it was determined that the damage was sustained in someplace external to the manufacturing environment.Based on all this information, the issue reported by the customer is not confirmed as the tip and all the splines were found still attached to the shaft of the device, even though some electrodes were found bent, the event description does not match with the findings detected during this investigation, therefore, they were considered as unrelated to the event.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device 30586133l number, and no internal actions related to the reported complaint condition were identified.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.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13101883
• MDR Text Key: 287583287
• Report Number: 2029046-2021-02261
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• 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: 30586133L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2021
• 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: UNK_CARTO VIZIGO SHEATH