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

Model Number D128208

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440)

Event Date 06/27/2022

Event Type  Injury  

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A device history record evaluation was performed for the finished device 30782491l number, and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a pentaray nav high-density mapping eco catheter and the patient suffered thrombosis and a cerebrovascular accident (cva).The patient suffered a suspected stroke while mapping the left ventricle for an ischemic vt procedure.Mapping only with the pentaray nav high-density mapping eco catheter was being performed in the left ventricle (lv) when the patient's blood pressure decreased.The patient's blood pressure was treated with vasopressors.The physician pulled catheters back and a thrombus was observed, on intracardiac echo that became dislodged from the lv.Shortly thereafter the patient displayed neurological symptoms consistent with stroke.The patient was being transported to radiology for a computed tomography (ct) scan.The patient received anticoagulation therapy during the procedure, and that the pentaray nav high-density mapping eco catheter was adequately irrigating while in use.The physician did not indicate that they believed bwi products were responsible for the patient event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15074114
• MDR Text Key: 296298141
• Report Number: 2029046-2022-01673
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30782491L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• 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