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 Myocardial Infarction (1969); Tachycardia (2095)

Event Date 01/26/2022

Event Type  Injury  

Event Description

It was reported that a female patient ((b)(6)) underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and suffered a myocardial infarction and ventricular tachycardia requiring surgical intervention.It was reported that during a cryo atrial fibrillation, a myocardial infarction or mi was noticed in the patient.It was noticed that the patient had st elevations on the recording system, and then the patient went into vt (ventricular tachycardia).The caller reported that the myocardial infarction was confirmed via the vt (ventricular tachycardia) seen on both the carto 3 and recording system.The medical intervention provided to the patient was an angioplasty.At the time of the call, the patient was reported to be in stable condition.The physician¿s opinion on the cause of this adverse event is that it was patient condition related.The patient had severe coronary artery disease.The patient has fully recovered and did not require extended hospitalization.The patient¿s diagnosed atrial fibrillation type pre¿procedure was paroxysmal.The patient was not in sinus rhythm during the entire procedure and did not develop atrial fibrillation during the procedure.Laboratory data: last act during procedure before event 369.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The device evaluation was completed on 11-mar-2022.It was reported that a female patient (80 kgs) underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and suffered a myocardial infarction and ventricular tachycardia requiring surgical intervention.It was reported that during a cryo atrial fibrillation, a myocardial infarction or mi was noticed in the patient.It was noticed that the patient had st elevations on the recording system, and then the patient went into vt (ventricular tachycardia).The caller reported that the myocardial infarction was confirmed via the vt (ventricular tachycardia) seen on both the carto 3 and recording system.The medical intervention provided to the patient was an angioplasty.At the time of the call, the patient was reported to be in stable condition.The physician¿s opinion on the cause of this adverse event is that it was patient condition related.The patient had severe coronary artery disease.The patient has fully recovered and did not require extended hospitalization.The patient¿s diagnosed atrial fibrillation type pre¿procedure was paroxysmal.The patient was not in sinus rhythm during the entire procedure and did not develop atrial fibrillation during the procedure.Laboratory data: last act during procedure before event 369.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection and an evaluation of all features of the catheter.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the pentaray nav high-density mapping eco catheter.Per the event, the magnetic, and electrical tests were performed, and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30657915l number, and no internal actions related to the reported complaint condition were identified.As part of bwi¿s quality process, all catheters are manufactured, inspected, and released to approved specifications.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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; 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: 13582987
• MDR Text Key: 287828151
• Report Number: 2029046-2022-00361
• 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,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• 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: 30657915L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2021
• 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: 7FR DECAN,11P,F,2.4MMLE,282MM,; CARTO 3 SYSTEM
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Female
• Patient Weight: 80 KG