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

Model Number M00522611

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to boston scientific corporation that a resolution clip device was used during a colonoscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the ¿long metal piece with the actual clip on it that opens and closes¿ fell inside the patient.Reportedly, the detached device was then removed, and 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 fine.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Investigation results: a visual examination of the returned complaint device noted that the clip assembly was half deployed, as the yoke was still attached to the control wire.The clip assembly had an over bite and the clip prongs were locked onto the capsule windows.There were no visual issues noted with the bushing or along the catheter.This failure is likely due to anatomical/procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used during a colonoscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the ¿long metal piece with the actual clip on it that opens and closes¿ fell inside the patient.Reportedly, the detached device was then removed, and 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 fine.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: RESOLUTION CLIP CLIPPING DEVICE
• Type of Device: CLIP, HEMOSTATIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7718314
• MDR Text Key: 115070780
• Report Number: 3005099803-2018-02443
• Device Sequence Number: 1
• Product Code: MCH
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2020
• Device Model Number: M00522611
• Device Catalogue Number: 2261
• Device Lot Number: ML001443C5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2017
• 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: 51 YR
• Patient Weight: 100