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

Model Number M00521230

Device Problem Defective Device (2588)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/01/2020

Event Type  Death  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2022 based on the date the manufacturer became aware of the event.The complainant was unable to report the suspected device lot number; therefore, the manufacture date and expiration date are unknown.This event was reported by the patient's family representative.The health care facility is: (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used in the polypous area of the stomach during a gastroscopy procedure performed on an unknown date.A patient's family member reported that the patient had a clip placed in the stomach.The clip came loose after 45 hours and caused a spontaneous hemorrhage where he died within a short time.Based on the family member's interpretation of the autopsy report "the autopsy report was clear that the clips had come loose and the bleeding that occurred was the likely cause of death.The clip that had come loose was placed on a polypous area".No further information has been obtained despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used in the polypous area of the stomach during a gastroscopy procedure performed on an unknown date.A patient's family member reported that the patient had a clip placed in the stomach.The clip came loose after 45 hours and caused a spontaneous hemorrhage where he died within a short time.Based on the family member's interpretation of the autopsy report "the autopsy report was clear that the clips had come loose and the bleeding that occurred was the likely cause of death.The clip that had come loose was placed on a polypous area".No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block b3: date of event: date of event was approximated to 10/01/2022 based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to report the suspected device lot number; therefore, the manufacture date and expiration date are unknown.Section e: this event was reported by the patient's family representative.The health care facility is: (b)(6), block h6: patient code e0506 captures the reportable event of patient hemorrhage.Impact code f02 is being used to capture the patient death.Block h11: correction: block g4 ((premarket / 510(k) #).

Manufacturer Narrative

Block b3: date of event: date of event was approximated to (b)(6) 2020 as the event date occurred approximately two years ago.Block h2: additional information: block b5 (describe event or problem) and h10 (additional mfr narrative) have been updated based on the additional information received on (b)(6) 2022.Block d4, h4: the complainant was unable to report the suspected device lot number; therefore, the manufacture date and expiration date are unknown.Section e: this event was reported by the patient's relative.The health care facility is: (b)(6) block h6: patient code e0506 captures the reportable event of patient hemorrhage.Impact code f02 is being used to capture the patient death.Block h11: correction: block b3 (date of event), b5 (describe event or problem), e1 (initial reporter name and email) and e3 (occupation (other)).

Event Description

It was reported to boston scientific that a resolution 360 clip was used during a gastroscopy procedure on an unknown date.A patient's family member reported that the patient had a clip placed in the stomach on a polypous area after a biopsy was performed.The clip came loose 45 hours after placement, resulting in a spontaneous hemorrhage and the patient passed away shortly thereafter.Based on the family member's interpretation of the autopsy report, the clips had come loose and the bleeding that occurred was the likely cause of death.It was reported that the patient experienced a spontaneous hemorrhage approximately 45 hours after the procedure and died.Additional information: boston scientific contacted the treating health care facility to request additional information.The facility reported that the incident occurred approximately two years ago and noted that information regarding the event was limited.The name of the treating physician was provided; however, no additional details regarding the event were provided, including the specific date of the procedure.

• 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: 15746461
• MDR Text Key: 303213492
• Report Number: 3005099803-2022-06558
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875628
• UDI-Public: 08714729875628
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K222503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00521230
• Device Catalogue Number: 54772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Death
• Patient Sex: Male