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

Model Number M00522610

Device Problems Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the stomach during an endoscopic mucosal resection (emr) procedure performed on (b)(6), 2022.During the procedure, the physician used a clip to close the wound.Bleeding clip and thermosetting wound.After closing, the tip of the device could not dropped off.After repeated manipulation of the handle and twisting and shaking of the endoscopic surface, the device could not be dropped off.After that, the sheath catheter was forcibly pulled out, and the hemostatic clip fell off.The procedure was completed with another resolution clip.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.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block h6: medical device code a15 captures the reportable event of clip unable to release from catheter.Block h11: correction: blocks b5 (describe event or problem), b7 (other relevant history), g2 (report source), h6 (patient code and device code) and h10 (additional mfr narrative).

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the stomach during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip was unable to release from the catheter to deploy.Repeated attempts were made using handle manipulation by twisting and shaking of the endoscopic surface, but still unsuccessful.Ultimately, the catheter was forcibly pulled out from the patient and the clip fell off which caused the wound to stretch and bleed.The procedure was completed with another resolution clip.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.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the stomach during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure, the physician used a clip to close the wound.Bleeding clip and thermosetting wound.After closing, the tip of the device could not dropped off.After repeated manipulation of the handle and twisting and shaking of the endoscopic surface, the device could not be dropped off.After that, the sheath catheter was forcibly pulled out, and the hemostatic clip fell off.The procedure was completed with another resolution clip.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.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block h6: medical device code a15 captures the reportable event of clip unable to release from catheter.Block h11: correction: blocks b5 (describe event or problem), b7 (other relevant history), g2 (report source), h6 (patient code and device code) and h10 (additional mfr narrative).Block h10: investigation analysis.The returned resolution clip device was analyzed, and a visual evaluation noted that the clip was returned without its oversheath and without the clip assembly.Additionally, the device had evidence of premature deployment (yoke is attached to the control wire).Microscopic examination was performed and it was found that the bushing has hits.No problems with the device were noted.The reported event of clip unable to release from catheter was not confirmed.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 labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• 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: 15542519
• MDR Text Key: 306682853
• Report Number: 3005099803-2022-05623
• Device Sequence Number: 1
• Product Code: MCH
• UDI-Device Identifier: 08714729504818
• 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,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2022

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: M00522610
• Device Catalogue Number: 2261
• Device Lot Number: 0029148766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 10/05/2022; 11/11/2022
• Supplement Dates FDA Received: 11/01/2022; 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2022
• 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
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 50 KG