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

Model Number M00522612

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Conclusion is being used in lieu of an adequate conclusion for device not returned.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used in colonoscopy on unknown date.According to the complaint, the clip failed to deploy.It was noted the procedure was completed with another resolution 360 clip device.There were no patient complications reported as a result to this event.The patient condition at the end of the procedure was reported to be stable.

Manufacturer Narrative

Block b3: date of event: date of event was approximated to (b)(6) 2022 based on the date the manufacturer became aware of the event.Block h6: medical device code a15 captures the reportable event of clip unable to deploy.Block h10: investigation results: the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned with the clip assembly stuck into the bushing and with evidence of full deployment.The device was returned without the over-sheath.Microscopic examination was performed and it was found that the capsule was deformed due to the entrapment of the clip with the bushing.The locking tabs were opened and the yoke was detached from the control wire, indicating a correct deployment.Additionally, the bushing had hit marks.No other problems with the device were noted.The reported event of clip unable to deploy was not confirmed.Investigation found that the bushing had hit marks which is likely due to the interaction between the yoke and the capsule, and/or due to the clip entrapment.Regarding the entrapment of the clip into the bushing, this is likely due to operational factors, such as activating the clip assembly and trying to open the clip after the first activation, causing a soft deployment.Furthermore, when the customer pulled back the handle for closing the arms again, this action induced that the capsule got localized incorrectly on the bushing, thereby causing the capsule to become stuck into the bushing.While, the physician kept pulling back the handle in order to release the clip assembly, this technique generated that the yoke got detached from the control wire.Additionally, the entrapment could have also contributed to the deformation found on the clip assembly.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.A review of manufacturing documentations for this device revealed no anomalies or deviations to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used during a colonoscopy procedure performed on an unknown date.During the procedure, the clip was unable to deploy.It was noted that the procedure was completed with another resolution clip device.There were no patient complications reported as a result to this event.

• Brand Name: RESOLUTION CLIP CLIPPING DEVICE
• 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: 14916452
• MDR Text Key: 303393091
• Report Number: 3005099803-2022-03614
• Device Sequence Number: 1
• Product Code: MCH
• UDI-Device Identifier: 08714729504818
• UDI-Public: 08714729504818
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2022

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
• Device Model Number: M00522612
• Device Catalogue Number: 2261
• Device Lot Number: 0029043743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 07/05/2022
• Supplement Dates Manufacturer Received: 07/06/2022
• Supplement Dates FDA Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2022
• 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