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	Abdominal Pain (1685); Unspecified Infection (1930); Inflammation (1932); Perforation (2001)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: patient code e2114 captures the reportable event of perforation.Impact code: f1901 captures the reportable event of additional surgery.Block a4: patient weight 160.3 and bmi 24.37.
Event or Problem Description
It was reported to boston scientific corportation that an x-tack endoscopic helix tacking system was used to close a mucosal defect in the ascending colon on (b)(6) 2023.The procedure was deemed a technical success, and the patient was discharged home with no restriction the day of (b)(6) 2023.The patient had a perforation and had a right hemicolectomy with anastomosis procedure on (b)(6) 2023.
Additional Manufacturer Narrative
Block h6: patient code e2114 captures the reportable event of perforation.Impact code: f1901 captures the reportable event of additional surgery.Block a4: patient weight 160.3 and bmi 24.37.Correction: impact code: f08 captures the reportable event of hospitalization.Impact code f2203: captures the reportable event of imagining required.
Event or Problem Description
It was reported to boston scientific corportation that an x-tack endoscopic helix tacking system was used to close a mucosal defect in the ascending colon on (b)(6) 2023.The procedure was deemed a technical success, and the patient was discharged home with no restriction the day of (b)(6) 2023.The patient presented to the emergency department on (b)(6) 2023 with right lower quadrant abdominal pain.A ct was preformed where it showed pneumoperitoneum concerning perforation.The patient underwent an exploratory laparotomy where perforation was noted in the ascending colon.During the exploratory laparoscopic procedure, right hemicolectomy with anastomosis was performed with cholecystectomy for inflamed gallbladder, subcutaneous wound vac was applied to the skin.On (b)(6) 2023, the patient underwent wall irrigation and debridement with wound vac placement.On (b)(6) 2023, the patient underwent abdominal wound closure with staples and incisional wound vac.
Event or Problem Description
It was reported to boston scientific corportation that an x-tack endoscopic helix tacking system was used to close a mucosal defect in the ascending colon on (b)(6) 2023.The procedure was deemed a technical success, and the patient was discharged home with no restriction the day of (b)(6) 2023.The patient presented to the emergency department on (b)(6) 2023 with right lower quadrant abdominal pain.A ct was preformed where it showed pneumoperitoneum concerning perforation.The patient underwent an exploratory laparotomy where perforation was noted in the ascending colon.During the exploratory laparoscopic procedure, right hemicolectomy with anastomosis was performed with cholecystectomy for inflamed gallbladder, subcutaneous wound vac was applied to the skin.On (b)(6) 2023, the patient underwent wall irrigation and debridement with wound vac placement.On (b)(6) 2023, the patient underwent abdominal wound closure with staples and incisional wound vac.
Additional Manufacturer Narrative
Block h6: patient code e2114 captures the reportable event of perforation.Impact code: f1901 captures the reportable event of additional surgery.Block a4: patient weight 160.3 and bmi 24.37 correction: impact code: f08 captures the reportable event of hospitalization.Impact code f2203: captures the reportable event of imagining required.

• 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: 18290455
• Report Number: 3005099803-2023-06605
• Device Sequence Number: 6762139
• Product Code: PKL
• UDI-Device Identifier: 20811955020760
• UDI-Public: 20811955020760
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2024

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
• Device Lot Number: AF05023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 02/01/2024; 02/20/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 02/05/2024; 02/28/2024
• 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
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White