MAUDE Adverse Event Report: APOLLO ENDOSURGERY X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (160CM); HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number	XTACK-160-H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); Vomiting (2144)
Date of Event	02/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf patient code e1020 captures the reportable event of nausea.Imdrf patient code e1032 captures the reportable event of vomiting.Imdrf impact code f08 captures the reportable event of hospitalization or prolonged hospitalization.Imdrf impact code f2303 captures the reportable event of medication required.
Event or Problem Description
It was reported to boston scientific corporation that an x-tack endoscopic helix tacking system (160cm) was used during an endoscopic submucosal dissection procedure for a fistula of the stomach on (b)(6) 2022.Following the procedure, the patient experienced nausea and vomiting.The patient was hospitalized for observation and medication was prescribed.There were no other patient complications as a result of this event.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that an x-tack endoscopic helix tacking system (160cm) was used during an endoscopic submucosal dissection procedure for a fistula of the stomach on (b)(6) 2022.Following the procedure, the patient experienced nausea and vomiting.The patient was hospitalized for observation and medication was prescribed.There were no other patient complications as a result of this event.No further information has been obtained despite good faith efforts.Additional information: a follow up endoscopy was done on (b)(6) 2022.
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf patient code e1020 captures the reportable event of nausea.Imdrf patient code e1032 captures the reportable event of vomiting.Imdrf impact code f08 captures the reportable event of hospitalization or prolonged hospitalization.Imdrf impact code f2303 captures the reportable event of medication required.Imdrf impact code f2202 captures the reportable event of endoscopic procedure.Block h10: per additional information received on 1mar2024.

• Brand Name: X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (160CM)
• Common Device Name: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1 suite 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA S.R.L; alajuela, 02 ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18314231
• Report Number: 3005099803-2023-06655
• Device Sequence Number: 6643664
• Product Code: PKL
• UDI-Device Identifier: 20811955020760
• UDI-Public: 20811955020760
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K201808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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 Model Number: XTACK-160-H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White