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

Device Problem Defective Device (2588)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/29/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used in the stomach during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2021.During the procedure, the patient had a pedunculated polyp removed, lifted with orise gel and closed with a resolution 360 prophylactically.According to the physician's assessment, on post-procedure, the patient had actually started bleeding in recovery immediately.This was not communicated to the physician at the time and the patient was later discharged and sent home.It was reported that the patient continued to bleed heavily once home.The patient returned the following day and required four units of blood.Upon re-scoping, the physician noted the clip had loosened, and two to three more clips was placed alongside the defect.Bleeding was stopped and the patient will be kept for observation.The physician believed it to be coincidental and not related to any use of orise gel.The patient is not on any apt/act.The patient outcome was expected to fully recover.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number and upn; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: RESOLUTION 360 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: 13087213
• MDR Text Key: 282770899
• Report Number: 3005099803-2021-07964
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2021

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization