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

Catalog Number D128208

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 09/12/2019

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device 30242586l number, and no internal actions related to the complaint was found during the review.Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a female patient underwent atrial fibrillation ablation procedure with a pentaray nav high-density mapping eco catheter and suffered an air embolism requiring no intervention.During the procedure the patient was noted to have st elevation on their ekg.The cardiologist was called, the coronary artiest were not blocked and an echo was performed at the bedside that discovered mini micro bubbles in the left ventricle.When the physician saw the bubbles the irrigation bag had been dry and needed replacement and the assumption is that it was the cause of the bubbles.In addition to the pentaray nav high-density mapping eco catheter, there were other, unspecified, irrigated products inserted at the time of the event.However, neither these products nor the pentaray nav high-density mapping eco catheter were connected to a pump.No intervention nor extended hospitalization was required.The patient is stable and reported to be fully recovered.The physician¿s opinion is this event was related to the procedure.No bwi product deficiencies were reported.Currently there is no information whether the pentaray was connected to the pump and therefore deficiency for pump will be coded.The patient¿s diagnosis pre-procedure was atrial fibrillation (afib).

• 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9160084
• MDR Text Key: 161516156
• Report Number: 2029046-2019-03728
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: 10846835012224
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2022
• Device Catalogue Number: D128208
• Device Lot Number: 30242586L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/14/2019
• 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): Life Threatening