MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NOGA-STAR CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	120708S
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 or Problem Description
It was reported that a (b)(6) female patient ((b)(6)) underwent a 3d noga mapping and during the mapping procedure with a noga-star catheter, the patient suffered aortic dissection requiring vascular consultation and multiple tests.During a clinical trial for stem cell therapy, dcmii, an adverse event occurred.It was reported that this was a two-part procedure.The first part is a 3d noga mapping and during the mapping procedure, the patient experienced a grade three severe adverse event.The patient had a retrograde distal aortic dissection.The catheter was advanced and the patient started experiencing pain.Vascular surgery was called and they did an aortic angiogram.Based on the angiogram, there was no compromise to the renal perfusion.The patient remained hemodynamically stable.Their conclusion was that there was a retrograde aortic dissection.The sheath was withdrawn from the catheter and it was recommended that they carefully advance a 5 fr omni flush catheter (with the pigtail) into the true lumen of the aorta using cineangiography.Multiple angiograms were taken and it was concluded that there was no compromise of renal perfusion, none of the cineangiograms showed a hang-up of contrast or extravasation.The patient did not require surgical repair.The patient was stable.The patient had a ct scan and was admitted to the hospital for observation and stayed less than 24 hours.The patient has since been discharged.The vascular surgeon stated that the patient is cleared to continue with the procedure, however, the investigator recommended rescheduling the procedure one month later following another ct scan.It was reported that they used a ref star plus reference patch, a noga star interface cable, and a noga star mapping catheter (curve f).There was no injection catheter used for the procedure.The patient is scheduled to have a follow up ct scan on (b)(6) 2021.Upon discharge, the ct showed aortic dissection from the level just below the celiac trunk to the proximal right common iliac artery.False lumen appears to be the smaller lumen supplies only the inferior mesenteric artery.The physician¿s opinion on the cause of this adverse event was that it was procedure and patient condition related.It was noted that the cineangiograms showed that there was some calcification in the distal aorta and it was thought that the sheath may have shifted position slightly during the attempt of passing an exchange wire and the shifting position may have led to the wire causing the retrograde dissection.
Additional Manufacturer Narrative
The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 23-nov-2021.The device evaluation was completed on 09-dec-2021.It was reported that a 50-year-old female patient (200lbs) underwent a 3d noga mapping and during the mapping procedure with a noga-star catheter, the patient suffered aortic dissection requiring vascular consultation and multiple tests.During a clinical trial for stem cell therapy, dcmii, an adverse event occurred.It was reported that this was a two-part procedure.The first part is a 3d noga mapping and during the mapping procedure, the patient experienced a grade three severe adverse event.The patient had a retrograde distal aortic dissection.The catheter was advanced and the patient started experiencing pain.Vascular surgery was called and they did an aortic angiogram.Based on the angiogram, there was no compromise to the renal perfusion.The patient remained hemodynamically stable.Their conclusion was that there was a retrograde aortic dissection.The sheath was withdrawn from the catheter and it was recommended that they carefully advance a 5 fr omni flush catheter (with the pigtail) into the true lumen of the aorta using cineangiography.Multiple angiograms were taken and it was concluded that there was no compromise of renal perfusion, none of the cineangiograms showed a hang-up of contrast or extravasation.The patient did not require surgical repair.The patient was stable.The patient had a ct scan and was admitted to the hospital for observation and stayed less than 24 hours.The patient has since been discharged.The vascular surgeon stated that the patient is cleared to continue with the procedure, however, the investigator recommended rescheduling the procedure one month later following another ct scan.It was reported that they used a ref star plus reference patch, a noga star interface cable, and a noga star mapping catheter (curve f).There was no injection catheter used for the procedure.The patient is scheduled to have a follow up ct scan on (b)(6) 2021.Upon discharge, the ct showed aortic dissection from the level just below the celiac trunk to the proximal right common iliac artery.False lumen appears to be the smaller lumen supplies only the inferior mesenteric artery.The device was returned to biosense webster inc.(bwi) for evaluation.A visual inspection, deflection, magnetic sensor functionality, and ecg tests of the returned device were performed in accordance with bwi procedures.Visual analysis of the returned noga-star catheter revealed that no damage or anomalies were observed on the device.A deflection test was performed, and the device passed deflection within specification.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly, no magnetic sensor-related issues were detected.An electrical test was performed, and no electrical issues were found.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.A manufacturing record evaluation was performed for the finished device 30418872m, and no internal action was found during the review.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: NOGA-STAR CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12724623
• Report Number: 2029046-2021-01846
• Device Sequence Number: 4028699
• Product Code: DRF
• UDI-Device Identifier: 10846835002058
• UDI-Public: 10846835002058
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K954390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/09/2023
• Device Model Number: 120708S
• Device Catalogue Number: 120708S
• Device Lot Number: 30418872M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OMNI¿ FLUSH 5FR CATHETER; UNK NOGA STAR INTERFACE CABLE; UNK NOGA STAR MAPPING CATHETER (CURVE F); UNK_NOGA REFSTAR PATCH
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 91 KG