MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 ULTRA CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number M00521402

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

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

Event Date 01/29/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of clip unable to deploy.

Event Description

It was reported to boston scientific corporation that a resolution 360 ultra clip device was used during an esophagogastroduodenoscopy (egd) with polypectomy procedure for gerd performed on (b)(6) 2024.During the procedure, the doctor performed a polypectomy and need to clip the defect.They placed the clip in the location the doctor wanted but when they deployed it, it didn't deploy properly.The procedure was completed with another resolution 360 ultra clip device.There were no patient complications have been reported as a result of this event.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block h2: additional information: block b5 (describe event or problem).Block h6: imdrf device code a15 captures the reportable event of clip unable to deploy.Block h10: investigation results the returned resolution 360 ultra clip device was analyzed, and a visual evaluation noted that the device has evidence of full deployment.Also, the customer provided a picture of the device inside its pouch without any visible problem.No other problems with the device were noted.The reported event of the clip could not be deployed was not confirmed.The investigation found that the device was returned without the clip assembly and with evidence of full deployment, indicating that the clip did release from the catheter.However, it is important to mention that the presence of the clip assembly is very important to the investigation in order to analyze any failure that could contribute with the problem faced by the physician.Additionally, it is important to take into consideration that during the product analysis, the dimensions between the hooks of the bushing were measured, and they were within specification, excluding the possibility that the device components dimensions interfered with the device performance.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.

Event Description

It was reported to boston scientific corporation that a resolution 360 ultra clip device was used during an esophagogastroduodenoscopy (egd) with polypectomy procedure for gerd performed on (b)(6) 2024.During the procedure, the doctor performed a polypectomy and need to clip the defect.They placed the clip in the location the doctor wanted but when they deployed it, it didn't deploy properly.The procedure was completed with another resolution 360 ultra clip device.There were no patient complications have been reported as a result of this event.No further information has been obtained despite good faith efforts.Additional information was received on 20feb2024.The anatomy location was colon.

Manufacturer Narrative

Block h2: additional information: block b5 (describe event or problem).Block h6: imdrf device code a15 captures the reportable event of clip unable to deploy.Block h10: investigation results the returned resolution 360 ultra clip device was analyzed, and a visual evaluation noted that the device has evidence of full deployment.Also, the customer provided a picture of the device inside its pouch without any visible problem.No other problems with the device were noted.The reported event of the clip could not be deployed was not confirmed.The investigation found that the device was returned without the clip assembly and with evidence of full deployment, indicating that the clip did release from the catheter.However, it is important to mention that the presence of the clip assembly is very important to the investigation in order to analyze any failure that could contribute with the problem faced by the physician.Additionally, it is important to take into consideration that during the product analysis, the dimensions between the hooks of the bushing were measured, and they were within specification, excluding the possibility that the device components dimensions interfered with the device performance.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.

Event Description

It was reported to boston scientific corporation that a resolution 360 ultra clip device was used during an esophagogastroduodenoscopy (egd) with polypectomy procedure for gerd performed on (b)(6) 2024.During the procedure, the doctor performed a polypectomy and need to clip the defect.They placed the clip in the location the doctor wanted but when they deployed it, it didn't deploy properly.The procedure was completed with another resolution 360 ultra clip device.There were no patient complications have been reported as a result of this event.***additional information was received on 19mar2024*** the type of procedure was colonoscopy.

• Brand Name: RESOLUTION 360 ULTRA CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• 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: 18742122
• MDR Text Key: 336873701
• Report Number: 3005099803-2024-00630
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729997269
• UDI-Public: 08714729997269
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222503
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00521402
• Device Catalogue Number: 2140
• Device Lot Number: 0032318644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2023
• 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