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

Model Number	M00522600
Medical Device Problem Codes	Defective Device (2588); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).(b)(4).Investigation results: the returned resolution clip device was analyzed, and a visual evaluation noted that the device was received with the clip assembly attached and with evidence of flaring from the capsule into the bushing.It was also observed that the control wire was highly kinked next to the spool and the device was returned without its outer-sheath.Microscopic examination was performed and it was found that the clip assembly was activated and the capsule bottom part was widened.The bushing tabs were rounded.Dimensional analysis was performed on the bushing outer diameter, and it was found to be within specification.A dimensional analysis was also performed between the hooks of the bushing and the pin gage, and both were confirmed to be out of specification.No other problems with the device were noted.Based on the condition of the returned device, the reported event of device damage was confirmed.Investigation found that the hooks of the bushing were out of specification and the capsule tabs were rounded with evidence of flaring of the capsule into the bushing which can be traced to the manufacturing process as a contributing factor and may have contributed to a clip deployment problem.Additionally, the hit marks found on the bushing is likely due to the flaring of the capsule onto the bushing.Therefore, the most probable root cause is manufacturing deficiency, as the reported event was traced to the manufacturing process.An investigation to address this problem is in progress.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used during a colonoscopy procedure performed on (b)(6) 2022.During unpacking, it was noticed that the device was damaged.The procedure was completed with another resolution clip device.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.This event has been deemed a reportable event based on the investigation findings of bushing hooks were out of specification and the bushing tabs were rounded, leading to a deployment problem.

• 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: 14079302
• Report Number: 3005099803-2022-01900
• Device Sequence Number: 14771390
• Product Code: MCH
• UDI-Device Identifier: 08714729504764
• UDI-Public: 08714729504764
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K040148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2023
• Device Model Number: M00522600
• Device Catalogue Number: 2260
• Device Lot Number: 0025076831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2020
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 70 KG