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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 06/25/2020

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.The customer did provide video of the reported event.According to video provided by customer, no clot was observed on screen.The video does not provide enough information related to the reported event and therefore no result can be obtained from it.The customer complaint cannot be confirmed from video analysis, therefore, it is s not possible to determine the root cause of the failure.A manufacturing record evaluation was performed for the finished, and no internal actions related to the reported complaint condition were identified.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 (b)(6) years old, female patient underwent atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter where blood clot occurred.It was reported that during the case, after going transseptal and right after the pentaray nav high-density mapping eco catheter was introduced to the body, a clot was discovered near the shaft of the pentaray nav high-density mapping eco catheter, close to the sheath.The physician decided not to continue with the procedure and the case was canceled.No medical intervention was reported.The only device inside the patient was the pentaray catheter and sheath.There was no report of patient consequence.There was no report of extended hospitalization.On 6/29/2020, additional information was received.It was reported that the event was discovered during use of the bwi product.The physician was unsure about the cause of the event.The event did not require medical or surgical intervention.The patient had fully recovered.The patient did not require extended hospitalization.No ablation catheter was used in this procedure.The system did not provide any error messages.There were no issues with temperature or flow in the catheter.The patient was anticoagulated.Activated coagulation time (act) practice is in the 350 seconds range and was maintained throughout the procedure.Heparinized normal saline was the only saline used.No neurological symptoms were observed since the procedure.

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10318253
• MDR Text Key: 200283007
• Report Number: 2029046-2020-00938
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• 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: Physician
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2023
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30390186L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2020
• 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: UNKNOWN SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 73 YR