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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT
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BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT Back to Search Results
Model Number M00521230
Device Problems Entrapment of Device (1212); Problem with Sterilization (1596)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2019
Event Type  Injury  
Manufacturer Narrative
Date of event was approximated to (b)(6) 2019 as the event date is unknown.(b)(4).According to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental mdr will be filed.Fda registration # mw5091534.
 
Event Description
It was reported to boston scientific corporation that a resolution 360 clip device from a previous procedure was lodged within the channel of the colonoscope that was used during a procedure performed on an unknown date.During a colonoscopy procedure performed on (b)(6) 2019, a resolution 360 clip misfired and became lodged inside the channel of the scope.This scope was removed from the patient and sent for cleaning and disinfection, and the procedure was completed with another scope and another resolution 360 clip device.Since brushes were run through the colonoscope during cleaning without resistance, and the clip was not found, it was believed that the clip had already been removed.Additionally, the scope was ran through the evotech and disinfection ran a normal course with no alarms engaged.Thus, the colonoscope was put back in service and was used in 11 patients.It was noted that resolution 360 clips were also used during the procedure on patient 8 without incident.During the procedure on last of the 11 patients, where resolution 360 clips were also used, it was reported that the physician tried to suction up a large polyp without success.Allegedly, upon pushing the polyp out of the channel, the clip that had been lodged in the scope came out with the polyp and was removed.It was confirmed that this clip did not belong to this patient.No patient complications have been reported due to this event.
 
Event Description
It was reported to boston scientific corporation that a resolution 360 clip device from a previous procedure was lodged within the channel of the colonoscope that was used during a procedure performed on an unknown date.During a colonoscopy procedure performed on (b)(6) 2019, a resolution 360 clip misfired and became lodged inside the channel of the scope.This scope was removed from the patient and sent for cleaning and disinfection, and the procedure was completed with another scope and another resolution 360 clip device.Since brushes were run through the colonoscope during cleaning without resistance, and the clip was not found, it was believed that the clip had already been removed.Additionally, the scope was ran through the evotech and disinfection ran a normal course with no alarms engaged.Thus, the colonoscope was put back in service and was used in 11 patients.It was noted that resolution 360 clips were also used during the procedure on patient 8 without incident.During the procedure on last of the 11 patients, where resolution 360 clips were also used, it was reported that the physician tried to suction up a large polyp without success.Allegedly, upon pushing the polyp out of the channel, the clip that had been lodged in the scope came out with the polyp and was removed.It was confirmed that this clip did not belong to this patient.No patient complications have been reported due to this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.***additional information received on (b)(6) 2020*** it was reported to boston scientific corporation that a resolution 360 clip device from a previous procedure was lodged within the channel of the colonoscope that was used during a colonoscopy procedure performed on november 13, 2019.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Additionally, it was reported that during a colonoscopy procedure performed on august 28, 2019, a resolution 360 clip grasped and locked onto tissue but failed to release from the catheter.During removal of the device, the clip became lodged inside the channel of the scope.The colonoscope was put back in service and was used in 12 patients.
 
Manufacturer Narrative
Block h6: problem code 1596 and 1212 capture the reportable event of clip detached and remained in the working channel of the colonoscope, reprocessed, and used in a patient during another procedure.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned".Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.Fda registration # (b)(4).
 
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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
MDR Report Key9578332
MDR Text Key183917611
Report Number3005099803-2019-06505
Device Sequence Number1
Product Code PKL
UDI-Device Identifier08714729875628
UDI-Public08714729875628
Combination Product (y/n)N
PMA/PMN Number
K151802
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 02/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/03/2021
Device Model NumberM00521230
Device Catalogue Number54772
Device Lot Number0022962620
Was Device Available for Evaluation? No
Date Manufacturer Received01/28/2020
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age50 YR
Patient Weight95
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