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

Model Number M00522611

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 06/03/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a resolution clip device was used during an upper gastrointestinal endoscopy procedure preformed on (b)(6) 2022.During the procedure, the clip was attempted to be deployed; however, the clip did not detach from the catheter.No patient complications have been reported as a result of this event.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Initial reporter alternative phone number: (b)(6).Medwatch number: 4400150000-2022-8027.(b)(4).

Event Description

It was reported to boston scientific corporation that a resolution clip device was used during an upper gastrointestinal endoscopy procedure preformed on (b)(6) 2022.During the procedure, the clip was attempted to be deployed; however, the clip did not detach from the catheter.No patient complications have been reported as a result of this event.No further information has been obtained despite good faith efforts.Additional information received on august 26, 2022.The anatomy location of the procedure was in the stomach.It was reported that the clip was able to grasp and lock onto tissue; however, the clip did not detach from the catheter despite multiple attempts of opening and closing the handle.The device felt normal throughout all the deployment stages.The procedure was completed with another resolution clip device.There were no patient complications have been reported due to this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block g3: medwatch number: (b)(4).Block h2: additional information: block b5 (describe event or problem), b7 (other relevant history), e1 (initial reporter title, first name, last name, phone number and email), e3 (occupation), h6 (impact codes) and h10 (additional mfr narrative) have been updated based on the additional information received on august 26, 2022.Block h6: medical device code a15 captures the reportable event of clip did not detach from catheter.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used during an upper gastrointestinal endoscopy procedure preformed on (b)(6), 2022.During the procedure, the clip was attempted to be deployed; however, the clip did not detach from the catheter.No patient complications have been reported as a result of this event.No further information has been obtained despite good faith efforts.Additional information received on august 26, 2022.The anatomy location of the procedure was in the stomach.It was reported that the clip was able to grasp and lock onto tissue; however, the clip did not detach from the catheter despite multiple attempts of opening and closing the handle.The device felt normal throughout all the deployment stages.The procedure was completed with another resolution clip device.There were no patient complications have been reported due to this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block g3: medwatch number: (b)(4).Block h6: medical device code a15 captures the reportable event of clip did not detach from catheter.Block h10: investigation results: the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned without the clip assembly attached to the catheter and with evidence of premature deployment (yoke was attached to the control wire).The control wire was out of the catheter when returned and the handle was broken.Microscopic examination was performed, and it was found that the clip was deployed inside the over-sheath.The clip had the first activation performed.Dimensional examination was performed on the bushing outer diameter, and it was found to be within specification.A dimensional analysis was also performed between the hooks of the bushing and both sides were noted to be within specification.No other problems with the device were noted.The reported event of clip did not detach from catheter was not confirmed.Investigation found that the yoke was returned attached to the control wire, this is likely due to operational factors during the procedure such as trying to open the clip once it was already activated.Regarding the found problem of handle broken, this is likely due to the adversities faced by the physician at the time of deployment of the clip.Additionally, it is important to take in 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 investigation findings and all information available do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is cause not established.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 CLIPPING DEVICE
• 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: 15330979
• MDR Text Key: 302843031
• Report Number: 3005099803-2022-04746
• Device Sequence Number: 1
• Product Code: MCH
• UDI-Device Identifier: 08714729504801
• UDI-Public: 08714729504801
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2022

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: M00522611
• Device Catalogue Number: 2261
• Device Lot Number: 0029080542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 08/26/2022; 10/03/2022
• Supplement Dates FDA Received: 09/02/2022; 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2022
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Race: White