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

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date (b)(6) 2022 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.Medical device problem code: (b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the colon during a colonoscopy procedure.The exact date of the procedure was not provided.During the procedure, the clip would not release from the catheter.Reportedly, the catheter was pulled off and maneuvered which caused a bleed.The procedure was completed successfully with a non-bsc clip device.The patient condition at the conclusion of the procedure was reported 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: 13909319
• MDR Text Key: 288706047
• Report Number: 3005099803-2022-01605
• Device Sequence Number: 1
• Product Code: MCH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/24/2022

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: 03/02/2022
• Initial Date FDA Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female