MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION CLIP; CLIP, HEMOSTATIC

Device Problems Material Twisted/Bent (2981); Appropriate Term/Code Not Available (3191)

Patient Problem Swelling/ Edema (4577)

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.(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 Description

It was reported to boston scientific corporation that three resolution 360 clip devices were used during a colonoscopy procedure performed on (b)(6) 2021.During the procedure, the first resolution 360 clip device was attempted to be deployed; however, the clip arms bent backwards.Reportedly, the clip was retrieved.The same issue happened with the second and third resolution 360 clip devices.The procedure was rescheduled for the next day due to this event.It was reported that the patient experienced an edema and it was unknown where was the exact location of the patient edema.There was no reported specific treatment for the edema.However, the patient outcome was noted to be fully recovered.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: RESOLUTION CLIP
• Type of Device: CLIP, HEMOSTATIC
• 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: 11648091
• MDR Text Key: 248034046
• Report Number: 3005099803-2021-01548
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1