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 Contamination /Decontamination Problem (2895); Material Deformation (2976)

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

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no internal action related to the complaint was found during the review.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter.After removing the pentaray from the patient there was material from inside the catheter wrapped around the splines.One of the electrodes looked like it was loose.When the pentaray catheter was removed from the patient at the end of the procedure that there was material from inside the catheter wrapped around the splines.One of the electrodes looked like it was loose.It did not appear that there were any missing pieces.Sheath used in the case: bwi carto vizigo 8.5f.The physician did not experience resistance when introducing or retracting catheter.The insertion tool was used.The issue was found on the splines of the pentaray.Physician did not indicate difficulty maneuvering the pentaray.The material found is unknown, it looked like fishing wire coming out of the splines.No patient consequences were reported.Electrode damaged with foreign material is mdr-reportable.Foreign material on usable length of catheter is mdr-reportable.

• 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: 12850514
• MDR Text Key: 281079322
• Report Number: 2029046-2021-02025
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• 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: 30633570L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: No
• 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: VIZIGO SHEATH