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

Model Number M00521231

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the device has been disposed and is not available for return; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch 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, first clip locked onto tissue and successfully released and deployed onto tissue.However, the three subsequent clips had difficulty getting down the olympus colonoscope.Additionally, the clips grasped and locked onto tissue, but were unable to release from the catheter to deploy.In the stages of deployment, snap and crackle were felt but there was no pop.The procedure was completed with another resolution 360 clip device.There were no patient complications have been reported due to this event.

• 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): 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: 12933909
• MDR Text Key: 281748068
• Report Number: 3005099803-2021-07729
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875635
• UDI-Public: 08714729875635
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K151802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00521231
• Device Catalogue Number: 54773
• Device Lot Number: 0027772481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• 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