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

Model Number	M00522600
Medical Device Problem Codes	Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Facility name: (b)(6).Imdrf device code a15 captures the reportable event of clip could not fully deployed.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used in the esophagus during an endoscopic submucosal dissection esd procedure performed on (b)(6) 2023.During the procedure, the clip reached onto lesion; however, the clip could not fully deploy.The procedure was completed with another resolution clip device.Note: it was reported that the sheath was completely removed off of the device.As per ifu, the over sheath is supposed to be retracted to expose the clip and not removed from the catheter.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 Manufacturer Narrative
Block e1: facility name: (b)(6).Block h6: imdrf device code a15 captures the reportable event of clip could not fully deployed.Block h10: investigation results: the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned without its over sheath.It was also noted that the clip assembly detached from the bushing but attached to the control wire, evidence of soft deploy.Microscopic examination was performed, and it was found that the capsule bottom part is damaged.No other problems with the device were noted.The reported event of clip unable to release from catheter was not confirmed.Investigation found that the clip had evidence of soft deployment since the clip was detached from the bushing but still attached to the control wire.Also, after a microscope analysis, it was found that the capsule had both sides lifted, consequently, the root cause of the clip assembly detachment.Most likely during unpacking of the device, the clip was hit against a hard surface causing the damage on the capsule, this possible hit, lifted the locking tab, which function was to attach the clip to the bushing, therefore, with this component lifted, there was not enough subjection between the clip and the bushing, causing the reported failure on the device.Additionally, the device returned without the over sheath, and since the customer stated that it was intentionally removed.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure.A product labeling review identified that the device was not used per the instructions for use (ifu)/product label as the customer removed the sheath during procedure, which is not describe in the instructions for use.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used in the esophagus during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2023.During the procedure, the clip reached onto lesion; however, the clip could not fully deploy.The procedure was completed with another resolution clip device.Note: it was reported that the sheath was completely removed off of the device.As per ifu, the over sheath is supposed to be retracted to expose the clip and not removed from the catheter.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.

• Brand Name: RESOLUTION CLIP
• Common Device Name: 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: 16682850
• Report Number: 3005099803-2023-01771
• Device Sequence Number: 7967423
• Product Code: PKL
• UDI-Device Identifier: 08714729504764
• UDI-Public: 08714729504764
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K222503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2025
• Device Model Number: M00522600
• Device Catalogue Number: 2260
• Device Lot Number: 0029157828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 74 KG