MAUDE Adverse Event Report: BIOSENSE WEBSTER INC ESOPHASTAR¿ ESOPHAGEAL MAPPING CATHETER; CATHETER, ELECTRODE RECORDING

Model Number	F8ENNNNHSB
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a (b)(6) male patient (average build, exact weight unknown) underwent an atrial fibrillation (afib) ablation procedure with an esophastar¿ esophageal mapping catheter.The patient had significant bleeding from the soft palate towards the back of the nose.The patient suffered an esophageal bleeding that stated when they were ablating in the left atrium.The bleeding was seen from the patient mouth around the esophastar¿ esophageal mapping catheter.They halted the procedure and reversed the heparin.About 200 ml of blood was removed from the esophagus.The patient is stable and they are waiting to see if the bleeding stops.It is believed that the issue was caused by the esophastar¿ esophageal mapping catheter.The physician¿s opinion on the cause of this adverse event was it eventually was determined to be above the soft palate towards the back of the nose.Cause was determined to be from sticking the temperature probe through the nose.The anesthesiologist had our esophastar¿ esophageal mapping catheter taped to the temperature probe at one point during the procedure.She did not confirm whether it was still attached at time of injury or not.As this was a cranial bleed, the ablation catheter was tossed out and is not available.The patient had their nose cauterized, which reopened and had to be sutured.The patient stayed overnight due to this and extended length of the procedure.No error messages were observed on biosense webster equipment during the procedure.The esophastar¿ esophageal mapping catheter and temperature probe were inserted nasally instead of orally as the physician prefers.Esophastar¿ esophageal mapping catheter was monitored on the carto while creating fast anatomical mapping (fam) then disconnected.The esophageal injury unconfirmed by upper digestive video scope, determined to be cranial.Ear, nose and throat (ent) doctor confirmed it was at the back of the nose visually.Force visualization features used were dashboard, vector and visitag, the graph from ct, though ct was compared to carto maps.In the physician's opinion of the cause of this event was the temperature probe was the most likely culprit.Just unsure of whether the esophastar¿ esophageal mapping catheter was also inserted nasally.
Additional Manufacturer Narrative
Patient code of ¿no code available¿ represents ¿iatrogenic injury".The bwi product analysis lab received the device for evaluation on 30-mar-2022.The device evaluation was completed on 04-apri-2022.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and an evaluation of all features of the catheter.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the esophastar.Per the event, the magnetic test was performed, and no malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process, all catheters are manufactured, inspected, and released to approved specifications.The root cause of the adverse event remains unknown.The instructions for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.Manufacturer's reference number: (b)(4).

• Brand Name: ESOPHASTAR¿ ESOPHAGEAL MAPPING CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14015127
• Report Number: 2029046-2022-00704
• Device Sequence Number: 17710724
• Product Code: DRF
• UDI-Device Identifier: 10846835008227
• UDI-Public: 10846835008227
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K061463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2022

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: 01/06/2025
• Device Model Number: F8ENNNNHSB
• Device Catalogue Number: F8ENNNNHSB
• Device Lot Number: 30709425L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2022
• 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: UNKNOWN BRAND ABLATION CATHETER; UNK_CARTO 3
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male