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

Model Number M00522612

Device Problems Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)

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

Event Date 02/01/2022

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date (b)(6) 2022 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to the second of two resolution clip devices used in the same procedure.It was reported to boston scientific corporation that two resolution clip devices were used during a colonoscopy procedure.The exact date of the procedure was not provided.During the procedure, two clips "misfiring".The same issue occurred to the second resolution clip device.The procedure was completed with another resolution clip.It was also noted that the sheath was attempted to be completely removed prior to the procedure which is not describe in the instructions for use.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

Event Description

Note: this report pertains to the second of two resolution clip devices used in the same procedure.It was reported to boston scientific corporation that two resolution clip devices were used during a colonoscopy procedure.The exact date of the procedure was not provided.During the procedure, two clips "misfiring".The same issue occurred to the second resolution clip device.The procedure was completed with another resolution clip.It was also noted that the sheath was attempted to be completely removed prior to the procedure which is not describe in the instructions for use.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block b3: the exact date of the event is unknown.The provided event date 01feb2022 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: medical device problem code a15 captures the reportable event of clip misfiring.Block h10: investigation results the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned without the clip assembly attached.The outer-sheath was not returned with the device.Microscopic examination was performed and it was found that the device had evidence of premature deployment.It was also observed that the bushing had hit marks.Dimensional analysis was performed on the bushing outer diameter, and it was found to be within specification.A dimensional analysis was also performed to the yoke, and the lengths of various parts were within specification.No other problems with the device were noted.The reported event was confirmed.Investigation found that the bushing had hit marks, this is likely due to the interaction between the yoke and the capsule while trying to deploy the clip.The device was returned without the clip assembly and it is important to mention that the presence of this component is very important to the investigation in order to analyze any failure that could contribute with the problem faced by the physician.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 manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A product labeling review identified that the device was not used per the instructions for use (ifu)/product label as the outer-sheath was attempted to be completely removed prior to the procedure which is not describe in the instructions for use.

• 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: 13715193
• MDR Text Key: 287403689
• Report Number: 3005099803-2022-01289
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

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: 0028027371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 03/09/2022
• Supplement Dates Manufacturer Received: 03/28/2022
• Supplement Dates FDA Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2021
• 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