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

Model Number D128211

Device Problems Complete Blockage (1094); Display or Visual Feedback Problem (1184); Patient Device Interaction Problem (4001)

Patient Problem Ischemic Heart Disease (2493)

Event Date 02/06/2023

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 an atrial fibrillation (afib)ablation procedure with a pentaray nav high-density mapping eco catheter and experienced electrocardiogram st segment elevation.It was reported that after septal puncture, before intracardiac insertion of the catheter, the catheter (pentaray nav eco 7fr, lot 30932208l) was not able to be inserted into the vizigo.When the catheter was checked, the spine had been bent.The catheter was replaced with another pentaray nav lot 30932207l.At the time of right pulmonary vein (rpv) gap mapping after pulmonary vein isolation (pvi), for the second catheter (pentaray nav eco 7fr, d, 2-6-2 , lot 30932207l), the spine was not displayed frequently.When the catheter was taken out of the patient¿s body, no irrigation was observed.The catheter was connected to the smartablate (sa) pump and flushed, but no irrigation occurred, so the catheter was replaced.The issues were resolved with another pentaray nav sh replacement.Adverse event: st elevation (suspected air contamination).St elevation occurred twice during and after the procedure.Since the first adverse event was immediately after the second pentaray was found that no irrigation was observed, thrombus was suspected, and coronary artery angiography (cag) was performed.However, st returned to normal during preparation.Cag also showed no stenosis or embolus.The second adverse event occurred when the procedure was completed, and the sheath and the catheter were removed.The st immediately restored to the normal, and no imaging was performed.The physician's opinions on the relationship between the event and the product was that because of the first the event, the physician was very careful not to create air during the procedure.Since st returned too soon to be attributed to air, the cause of occurrence of the event is not clear.The resistance with sheath, shaft bent, occlusion/no irrigation, and visualization issues are not mdr reportable to the fda.Since the event (electrocardiogram st segment elevation) is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

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 04-apr-2023.It was reported that a patient underwent an atrial fibrillation (afib)ablation procedure with a pentaray nav high-density mapping eco catheter and experienced electrocardiogram st segment elevation.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a general inspection through the visual inspection and all features of the catheter tests.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the pentaray nav eco catheter.Per the event, several tests were performed.The magnetic features were tested, and no issues were observed.In addition, the product was deflecting correctly.An irrigation test was performed, in accordance with bwi procedures.The catheter failed the test since the irrigation tube was found folded inside the tip area, near electrode 22.No other damage was observed that may have contributed to the occlusion of the catheter.A manufacturing record evaluation (mre) was performed for the finished device number lot 30932207l and no internal action related to the complaint was found during the review.Based on the mre, the d4.Expiration date and h4.Device manufacture date have been updated.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The irrigation issue reported by the customer was confirmed.It should be noted that device failure is multifactorial.The instructions for use contain the following precautions: 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.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the adverse event.Investigation findings: operational problem identified (c13) / investigation conclusions: cause not established (d15) / component code: tube (g04134) were selected as related to the damage to the irrigation issue.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

Additional information was received on 29-mar-2023.It was reported that the resistance was between devices.There was resistance with the sheath when they were trying to put the catheter into the sheath.The damage did not result in wires being exposed nor did it result in any lifted or sharp rings.The patient outcome of the adverse event was fully recovered.A smartablate generator was used.Therefore, the concomitant product section was updated.The physician¿s name was provided.Therefore, the e.Initial reporter section was updated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) on the 3500a follow up report (b)(4), follow up type was indicated as "additional information" in addition to "device evaluation" however, the additional information was inadvertently left off.Therefore, the additional information was included in this report.

• 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: 16482758
• MDR Text Key: 310684807
• Report Number: 2029046-2023-00468
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• 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
• Device Lot Number: 30932207L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2022
• 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: 8.5F SHEATH WITH CURVE VIZ SMC; PENTARAY NAV ECO 7FR, D, 2-6-2; PENTARAY NAV ECO 7FR, D, 2-6-2; UNK_SMARTABLATE GENERATOR; UNK_SMARTABLATE PUMP
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male