MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 ULTRA CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number M00521401

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

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Perforation (2001)

Event Date 10/13/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a resolution 360 ultra clip device was used in the gastric during an esophagogastroduodenoscopy (egd) with poem procedure performed for the idiopathic gastroparesis on (b)(6) 2021.It was reported that the patient developed abdominal pain especially in the epigastric area and was found to have free air on a computerized tomography (ct) scan of the abdomen and pelvis.It was noted that the patient underwent exploratory laparotomy and egd which showed a 1cm perforation in the gastric mucosa.It was successfully oversewn by a non-bsc clip.Additionally, the patient also underwent exploratory laparotomy, lysis of adhesions, abdominal washout and repair of the gastric perforation.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Fda registration # mw5104989.(b)(4).The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental medwatch will be filed.

• Brand Name: RESOLUTION 360 ULTRA CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13224733
• MDR Text Key: 283593978
• Report Number: 3005099803-2022-00057
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729997252
• UDI-Public: 08714729997252
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00521401
• Device Catalogue Number: 2140
• Device Lot Number: 0027320196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2021
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Female