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

Model Number M00522610

Device Problems Defective Device (2588); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the intestinal tract during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the connection between the clip and catheter was observed to be bent.Reportedly, it was noted that the clip was difficult to advance out of the over-sheath.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block e1: initial reporter facility name: dongguan hospital of traditional chinese medicine block h6: device code 2588 captures the reportable event of the bushing bent.Block h10: investigaton results: the returned resolution clip device was analyzed, and a visual evaluation noted that the clip assembly was partially separated from the bushing, as the control wire was still attached to the clip assembly.Microscope examination was performed and it was noted that the capsule tabs were damaged; however, no evidence of activations that had been performed in the clip assembly.Additionally, due to the condition of the most distal section of the device, it was not possible to pass the sheath through the clip assembly.Functional evaluation could not be performed due to the device returned condition.The reported event was not confirmed.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the intestinal tract during an endoscopic submucosal dissection (esd) procedure performed on june 23, 2020.According to the complainant, during the procedure, the connection between the clip and catheter was observed to be bent.Reportedly, it was noted that the clip was difficult to advance out of the over-sheath.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

• Brand Name: RESOLUTION CLIP
• Type of Device: CLIP, HEMOSTATIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10298637
• MDR Text Key: 199869801
• Report Number: 3005099803-2020-02830
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729504795
• UDI-Public: 08714729504795
• Combination Product (y/n): N
• PMA/PMN Number: K040148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

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 Expiration Date: 10/09/2021
• Device Model Number: M00522610
• Device Catalogue Number: 2261
• Device Lot Number: ML001736C5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 08/10/2020
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 55