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 Partial Blockage (1065); Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 10/18/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that an unknown patient underwent a persistent atrial fibrillation (afib) ablation with a pentaray nav high-density mapping eco catheter.The patient suffered cerebrovascular accident post procedure requiring prolonged hospitalization.The reporter called back and he found out the patient had a stroke post procedure (same day).It is unknown if there was any intervention.It was also reported that the catheter stopped irrigating properly after being used for a few mins.Caller stated they tried flushing the catheter after they took it out of the body with no resolution.When the catheter was replaced, the issue resolved.Additional information: the physician¿s opinion on the cause of this adverse event: likely patient condition, but possibly bwi product malfunction.The patient required extended hospitalization because of the adverse event but details unknown.Generator information: smartablate & pump information: smartablate.There was no evidence of char during the procedure.No evidence of blood thrombus / clot during the procedure.The correct catheter settings were selected on the pump and the pump was switching from low to high flow during ablation.Since the event is life threatening and might result in permanent impairment of a body function or permanent damage of a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 11-nov-2021, the bwi 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

On 9-dec-2021, the product investigation was completed.It was reported that an unknown patient underwent a persistent atrial fibrillation (afib) ablation with a pentaray nav high-density mapping eco catheter.The patient suffered cerebrovascular accident post procedure requiring prolonged hospitalization.The medical staff called back and he found out the patient had a stroke post procedure (same day).It is unknown if there was any intervention.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the pentaray nav eco.Carto 3 was performed in accordance with bwi procedures.The catheter was visualized and recognized, and no errors were observed.Electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was 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 30625909l number, and no internal action related to the reported complaint condition were identified.No malfunction was observed during the product analysis.The instructions for use (ifu) states: flush the catheter with heparinized saline prior to insertion into the body.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.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: 12784307
• MDR Text Key: 280573321
• Report Number: 2029046-2021-01924
• 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,Followup
• Report Date: 12/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• 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: 30625909L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• 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: SMARTABLATE GENERATOR; SMARTABLATE PUMP
• Patient Outcome(s): Life Threatening; Hospitalization