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

Model Number D128208

Device Problems Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problem Rupture (2208)

Event Date 01/13/2021

Event Type  Injury  

Manufacturer Narrative

Device investigation details: information available indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30428035l 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.Initial reporter phone: (b)(6).Manufacturer's ref.#: (b)(4).

Event Description

It was reported that a male patient underwent a non-ischemic ventricular tachycardia (non-isvt) ablation procedure on which a pentaray nav high-density mapping eco catheter became entrapped in the patient¿s mitral valve causing cardiac valve rupture requiring no interventions.The patient was under general anesthesia.Retroartic access was used.During the procedure, while mapping an isvt, the pentaray catheter got entrapped in the mitral valve.The physician felt resistance while trying to remove the catheter; however, it was able to be removed from the patient¿s body without requiring surgery.When the catheter was out of the body, they noticed a part of the mitral valve was removed with the catheter.Physician decided to stop the procedure for safety reasons; however, there¿s no indication the patient developed any symptom or distress.No additional interventions were required.The physician stated the issue occurred because of the shape of the pentaray catheter and its splines as it is most likely to have this type of complications with this catheter compared to other ones.No internal components exposed, nor any lifted/sharp electrode was observed.

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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: 11298003
• MDR Text Key: 232157255
• Report Number: 2029046-2021-00141
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: 10846835012224
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2023
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30428035L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/19/2020
• 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
• Patient Outcome(s): Other