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 Entrapment of Device (1212)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 02/27/2020

Event Type  Injury  

Manufacturer Narrative

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a pentaray nav high-density mapping eco catheter, and a medical device entrapment issue occurred.During left atrium mapping a spline of the pentaray nav became entangled in prosthetic valve, ruptured, and remained in the patient¿s body.The physician managed to extract the detached component.A new catheter was used to complete the procedure.The physician¿s commented that i heard that mechanical valves are contraindicated but thought that they should be used with care.There was no report of patient consequence.The observed medical device entrapment has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

Additional information was received on the event on (b)(6)2020.The patient is a 56 year old male.The patient suffered a medical device entrapment requiring surgical intervention.The physician managed to extract the detached component in the coronary artery.The physician¿s opinion is that the cause of the event was the nature of the procedure.The condition of the patient has improved.Therefore, a 2.Patient age at the time of event, a 2.Age unit and a 3.Sex have been populated.Per the pentaray nav instructions for use, the use of this device in patients with prosthetic valves is contraindicated.Since device retrieval was required, it was assessed as a ¿surgical intervention¿.Therefore, updated a1.Is adverse event, a2.Is required intervention and h1.Type of reportable event.In addition, updated h6.Patient codes from "foreign body in patient" and "no consequences or impact to patient" to ¿no code available¿ which represents ¿surgical intervention." during an internal review on (b)(6)2020 , corrections were noted to the 3500a initial report: 1.B1.Brand name was populated 2.D10.Device available for evaluation? was originally left as blank and should have been populated as ¿no¿.3.Manufacturing record evaluation was omitted: a manufacturing record evaluation was performed for the finished device 30316382l number, and no internal actions related to the complaint was found during the review.4.Missing h6.Method codes: analysis of production records if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (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; 33 technology drive; irvine CA 92618
• MDR Report Key: 9871668
• MDR Text Key: 200665616
• Report Number: 2029046-2020-00458
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2022
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30316382L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR