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

Model Number F8ENNNNHSB

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/08/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 288614000
• Report Number: 2029046-2022-00704
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008227
• UDI-Public: 10846835008227
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061463
• 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: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2022
• 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: UNKNOWN BRAND ABLATION CATHETER; UNK_CARTO 3
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male