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 Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 06/01/2022

Event Type  Injury  

Event Description

It was reported that a female patient underwent a cardiac ablation procedure on (b)(6)2022 with a pentaray nav high-density mapping eco catheter and the patient suffered a cerebrovascular accident requiring prolonged hospitalization.The procedure was performed on (b)(6) 2022.A few weeks after that, the patient was in emergency transported to (b)(6) hospital on (b)(6) 2022.The physician reported this information to the bwi representative on (b)(6) 2022.It was initially reported the patient had atrio-esophageal fistula, but the issue was not life-threatening.The patient later suffered a cerebrovascular accident.According to the neurosurgeon at the hospital to which the patient was transferred, in his opinion, it was unrelated to ablation based on the results of detailed examination.The physician who did ablation procedure confirmed there were no abnormalities observed before and during use of the product.The patient medical history included diabetes mellitus.The patient developed cerebral infarction because foreign material entering into the heart from the esophageal side of the atrio-esophageal fistula and transferred to the brain.The patient survived, but the prognosis is very poor.The patient was hospitalized in intensive care unit (icu).It was later reported the initial information had been corrected.There was no atrioesophageal fistula, and no foreign material confirmed.The patient only developed cerebral infarction.It was reported only pentaray nav high-density mapping eco catheter was used in the procedure as a bwi product.There was no issue reported during the procedure.There was no evidence of char during the procedure and there was no evidence of thrombus / clot during the procedure.A filthy substance invaded the heart from the esophagus and jumped into the brain, causing a cerebral infarction.The life was saved, but the prognosis is quite poor.

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.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.Initial reporter phone: (b)(6).Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 8-aug-2022, additional information was received confirming that bwi ablation catheter was not used in this case.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14997823
• MDR Text Key: 295770752
• Report Number: 2029046-2022-01594
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2022
• 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
• Patient Outcome(s): Life Threatening