MAUDE Adverse Event Report: COVIDIEN LP BARRX UNKNOWN HALO 360; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number UNKNOWN HALO 360

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); Blood Loss (2597)

Event Date 07/26/2020

Event Type  Injury  

Manufacturer Narrative

Title outcomes of radiofrequency ablation by manual versus self-sizing circumferential balloon catheters for the treatment of dysplastic b arrett¿s esophagus: a multicenter comparative cohort study source american society for gastrointestinal endoscopy, 2020(1-25), date of acceptance: 26 july 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed, 90 patients were treated with halo 360 express catheter, 8 patients developed early stricture formation at a median of 53 days after first ablation.6 patients developed the stricture after use of the 12 joules ablation dose and 1 patient experienced a delayed stricture at 203 days after first ablation.All strictures were successfully managed with endoscopic dilation using bougie dilation, balloon dilation, or a combination of both.Patients underwent a median of 2 dilations for stricture resolution.1 patient with post operative bleeding had coronary artery disease and peripheral vascular disease, requiring dual antiplatelet therapy with aspirin and clopidogrel, which increases the risk of intra-procedural and post-procedural bleeding.Clopidogrel was held for the procedure and resumed the following day.16 days later, the patient presented with hematemesis.Endoscopy revealed circumferential esophageal ulcers with active oozing of blood.No endoscopic therapy was applied given diffuse oozing and the lack of a single treatable source.The patient was treated supportively with blood transfusion and was discharged without further bleeding.

• Brand Name: UNKNOWN HALO 360
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• Manufacturer (Section G): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 10525203
• MDR Text Key: 206774216
• Report Number: 3004904811-2020-00027
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN HALO 360
• Device Catalogue Number: UNKNOWN HALO 360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR