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

Model Number M00521231

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2020

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that three resolution 360 clips devices were used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, one of the clip arms fell off when the clip was opened inside the patient.The same issue occurred with the second and third resolution 360 clips.The procedure was not completed due to this event.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.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: conclusion code 4316 is being used to capture that the event is no longer reportable.Additional information: block b5 (event description), h6 (device code).

Event Description

It was reported to boston scientific corporation that three resolution 360 clips devices were used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, one of the clip arms fell off when the clip was opened inside the patient.The same issue occurred with the second and third resolution 360 clips.The procedure was not completed due to this event.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.***additional information received on (b)(6) 2020*** it was reported that the colonoscopy procedure performed on (b)(6), 2020 was successfully completed; however, it was decided that the procedure would be completed without any further attempts to place another clip.

• 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 Key: 10121219
• MDR Text Key: 194328094
• Report Number: 3005099803-2020-02200
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875635
• UDI-Public: 08714729875635
• Combination Product (y/n): N
• PMA/PMN Number: K151802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2022
• Device Model Number: M00521231
• Device Catalogue Number: 54773
• Device Lot Number: 0024100412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1