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

Model Number M00522610

Device Problems Premature Activation (1484); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2020, as the event date is unknown.(b)(4).Investigation results: the returned resolution clip device was analyzed, and a visual evaluation noted that the clip assembly came loose from the device.The clip assembly was inspected under high magnification, and it was noted that the first activation had not been performed, however, a plastic material was stuck inside of the clip assembly that cause the clip wings that could not be inside of the capsule windows.The device was disassembled for further analysis, and it was observed that the tension breaker was in good condition.The over sheath was also in good condition and thus, the plastic material found was not from this resolution clip device.No other issues with the device were noted.The investigation concluded that there is a lack of objective evidence or descriptive conditions of the event required to determine a definitive root cause of how a piece of the plastic material came inside the clip assembly.The investigation findings and all information available do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is cause not established.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A review of the instructions for use (ifu) and product labeling was completed and did not reveal any evidence of device misuse, or that the device was used in a manner inconsistent with the labeled indications.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used during a procedure performed on an unknown date.According to the complainant, during the procedure, the device was defective as the tip of the clip fell off making the procedure impossible.No patient complications have been reported as a result of this event.Investigation results showed that a plastic material was found stuck inside of the clip assembly and the plastic material found was not from the resolution clip device; therefore, this is now an mdr reportable event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used during a procedure performed on an unknown date.According to the complainant, during the procedure, the device was defective as the tip of the clip fell off making the procedure impossible.No patient complications have been reported as a result of this event.Investigation results showed that a plastic material was found stuck inside of the clip assembly and the plastic material found was not from the resolution clip device; therefore, this is now an mdr reportable event (see block h10 for investigation details).Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block b3: date of event was approximated to (b)(6) 2020 as the event date is unknown.Block h6: device code 2944 captures the investigation result of foreign material block h10: investigation results the returned resolution clip device was analyzed, and a visual evaluation noted that the clip assembly came loose from the device.The clip assembly was inspected under high magnification, and it was noted that the first activation had not been performed; however, a plastic material was stuck inside of the clip assembly that cause the clip wings that could not be inside of the capsule windows.The device was dissassembled for further analysis, and it was observed that the tension breaker was in good condition.The over sheath was also in good condition and thus, the plastic material found was not from this resolution clip device.No other issues with the device were noted.The investigation concluded that there is a lack of objective evidence or descriptive conditions of the event required to determine a definitive root cause of how a piece of the plastic material came inside the clip assembly.The investigation findings and all information available do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is cause not established.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A review of the instructions for use (ifu) and product labeling was completed and did not reveal any evidence of device misuse or that the device was used in a manner inconsistent with the labeled indications.Block h11: correction: block h6 (evaluation method codes).

• Brand Name: RESOLUTION CLIP
• Type of Device: CLIP, HEMOSTATIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10842916
• MDR Text Key: 216339131
• Report Number: 3005099803-2020-05340
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729504795
• UDI-Public: 08714729504795
• Combination Product (y/n): N
• PMA/PMN Number: K040148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2022
• Device Model Number: M00522610
• Device Catalogue Number: 2261
• Device Lot Number: ML001770C5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Date Manufacturer Received: 11/19/2020
• Patient Sequence Number: 1