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

Model Number M00521230

Device Problems Entrapment of Device (1212); Problem with Sterilization (1596)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2019

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to report the device lot number; therefore, the manufacture date and expiration date are unknown.(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 mdr will be filed.Mw5088198.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used during a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the clip device bent in a way such that the clip could not adhere to the tissue, and it could not be used.Reportedly, during removal of the clip device, the clip came off into the working channel of the endoscope.The procedure was completed at this time and the endoscope was reprocessed.During a separate procedure performed with the same endoscope on (b)(6) 2019, the retained clip was expelled into the colon of the patient.No patient complication have been reported as a result of the event.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• 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): FREUDENBERG MEDICAL MIS (FM MIS); north port industrial park; 2301 centennial boulevard,; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8984225
• MDR Text Key: 159183372
• Report Number: 3005099803-2019-04505
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875628
• UDI-Public: 08714729875628
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/10/2019

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
• Device Model Number: M00521230
• Device Catalogue Number: 54772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1