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

Model Number M00522610

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

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

Event Date 07/19/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the rectum during a gastrointestinal endoscopy procedure performed on (b)(6) 2022.During the procedure, after the clip was deployed, it was noticed that the yoke fell off and got stuck inside the tip of the scope.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the rectum during a gastrointestinal endoscopy procedure performed on (b)(6) 2022.During the procedure, after the clip was deployed, it was noticed that the yoke fell off and got stuck inside the tip of the scope.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.**additional information received on august 16, 2022.It was reported that the yoke that was stuck inside the scope was successfully removed; however, it is unknown what device or instrument was used to retrieve the yoke.

Manufacturer Narrative

Block h2: additional information: block b5 (describe event or problem) has been updated based on the additional information received on august 16, 2022.Block h6: medical device problem code a150208 captures the reportable event of yoke stuck in scope.Block h10: the device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the rectum during a gastrointestinal endoscopy procedure performed on (b)(6) 2022.During the procedure, after the clip was deployed, it was noticed that the yoke fell off and got stuck inside the tip of the scope.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on august 16, 2022: it was reported that the yoke that was stuck inside the scope was successfully removed; however, it is unknown what device or instrument was used to retrieve the yoke.

Manufacturer Narrative

Block h6: medical device problem code a150208 captures the reportable event of yoke stuck in scope.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 attached to the bushing.Microscopic examination was performed, and it was found that the clip was flared into the bushing.The clip had both activations performed since there was no communication with the handle.Additionally, the bushing had hit marks and the bushing tabs were rounded.No other problems with the device were noted.The reported event of yoke stuck in scope was not confirmed as the device was returned with the clip assembly attached to the catheter and with all its components inside the clip.Investigation found that the bushing 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 could have contribute to a clip deployment problem.Additionally, the hit marks found on the bushing is likely due to the flaring of the capsule into the bushing.Taking all available information into consideration, the most probable root cause of this event 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.

• Brand Name: RESOLUTION CLIP
• 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: 15229954
• MDR Text Key: 302680798
• Report Number: 3005099803-2022-04490
• Device Sequence Number: 1
• Product Code: MCH
• UDI-Device Identifier: 08714729504795
• UDI-Public: 08714729504795
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2023
• Device Model Number: M00522610
• Device Catalogue Number: 2261
• Device Lot Number: 0025083543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2020
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 70 KG