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

Model Number	M00521240
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.It was reported the device was not used past its expiry date.(b)(4).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.
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 clip device was used in a colonoscopy procedure on (b)(6) 2018.According to the complainant, during the procedure, the clip grasped and locked onto the tissue but failed to release from the catheter.The clip was finally released after 15 minutes, and the procedure was completed at this time.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: RESOLUTION 360¿ CLIP
• Common Device Name: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7311286
• Report Number: 3005099803-2018-00648
• Device Sequence Number: 19168241
• Product Code: PKL
• UDI-Device Identifier: 08714729875666
• UDI-Public: 08714729875666
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K151802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00521240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1