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

Catalog Number D128211

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a cryo atrial fibrillation (afib) ablation procedure and the patient experienced cerebrovascular accident that required medication and prolonged hospitalization.After three (3) hours of recovery, the patient began to show signs of stroke which included dysphasia & hemiparesis.The stoke was confirmed by a computed tomography (ct) scan.The only medical intervention provided to the patient was the medication tnk (tenecteplase) to dissolve the clot.The patient improved almost to baseline and was reportedly in stable condition.Additional information was received.Per the physician's partner, they were presenting with expressive aphasia.The patient required extended hospitalization due to drug thrombolysis.Activated clotting time (act) was therapeutic throughout the case.There was no evidence of blood thrombus/clot during the procedure.The physician's partner opined this was a procedural complication, and not a biosense webster inc.(bwi) product issue.Pentaray was on a pressure bag.This event will be conservatively reported under the pentaray catheter as it cannot be excluded as a contributing factor to the adverse event.

Manufacturer Narrative

If additional information is received regarding this event, it will be re-assessed for reportability.If deemed reportable, then a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 26-mar-2024, it was determined that there are no specific details stating that the pentaray catheter contributed to the stroke.A stroke after or during an ablation with cryo can be related to introducing air bubbles into the left atrium (la) due to exchanging catheters through a guiding sheath.Therefore, the most suspected device is the sheath.Additional information was received on 04-apr-2024, which indicated that the sheath used was a mdt flex sheath (non-biosense webster inc.(bwi) sheath).As such, this event is no longer considered mdr reportable against any bwi devices.The codes have been updated under h 6.Health effect - clinical code, h 6.Health effect - impact code, and h 6.Medical device problem code.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18804552
• MDR Text Key: 336507691
• Report Number: 2029046-2024-00676
• Device Sequence Number: 1
• Product Code: MTD
• 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,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D128211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: MEDTRONIC CRYO CONSOLE.; UNKNOWN CRYO CATHETER.; UNK_C3 EXTERNAL REFERENCE PATCH.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Male