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

Model Number M00522610

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 06/06/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used in a colonoscopy on (b)(6) 2022.According to the complaint, during the procedure, the clip was used to close the wound after excision, the clip could not fall off.The handle was repeatedly pushed and pulled, but it still could not fall off.Finally, it was pulled off together with the tissue, causing intestinal bleeding.After that, the clip was used again to stop the bleeding and close the wound.The procedure was completed with another resolution clip.There were no patient complication reported as a result to this event.The patient condition at the end of the procedure was reported to be stable.

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 medwatch 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 mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure, the clip was used to close the wound after excision; however, the clip could not fall off.The handle was then repeatedly pushed and pulled, but still the clip could not fall off.Finally, the clip was pulled off together with the tissue, causing intestinal bleeding.Another resolution clip device was used to stop the bleeding and the procedure was completed successfully.There were no patient complication reported as a result to this event.The patient's condition at the end of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: medical device code a15 captures the reportable event of clip unable to release from the 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 and the device had evidence of premature deployment.The device was returned without the over-sheath.Microscopic examination was performed, and it was found that the yoke was attached to the control wire and there was a piece of the tension breaker still attached to the yoke.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 unable to release from the catheter was not confirmed.Investigation found that the yoke was returned attached to the control wire, this could be due to operational factors during the procedure such as trying to open the clip once it was already activated.The device was returned without the clip assembly and it is important to mention that the presence of this component 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 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 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 review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Block h11: correction: block b5 (describe event or problem), b7 (other relevant history), d4 (model number), e1 (initial reporter title, first name, last name, address 1, address 2, city, zip/post code, phone and email), g1 (mfr site facility name and mfr site address 2), g2 (report source and report source (other)), h6 (patient codes), and h10 (additional mfr narrative).

Manufacturer Narrative

Block h6: medical device code a15 captures the reportable event of clip unable to release from the 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 and the device had evidence of premature deployment.The device was returned without the over-sheath.Microscopic examination was performed, and it was found that the yoke was attached to the control wire and there was a piece of the tension breaker still attached to the yoke.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 unable to release from the catheter was not confirmed.Investigation found that the yoke was returned attached to the control wire, this could be due to operational factors during the procedure such as trying to open the clip once it was already activated.The device was returned without the clip assembly and it is important to mention that the presence of this component 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 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 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 review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.Block h11: correction: block h10 (investigation results) labeling review performed.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the intestinal tract during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure, the clip was used to close the wound after excision; however, the clip could not fall off.The handle was then repeatedly pushed and pulled, but still the clip could not fall off.Finally, the clip was pulled off together with the tissue, causing intestinal bleeding.Another resolution clip device was used to stop the bleeding and the procedure was completed successfully.There were no patient complication reported as a result to this event.The patient's condition at the end 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
• 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: 14842758
• MDR Text Key: 303234294
• Report Number: 3005099803-2022-03509
• Device Sequence Number: 1
• Product Code: MCH
• UDI-Device Identifier: 08714729504795
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2022

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: 0027940368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 08/22/2022; 09/27/2022
• Supplement Dates FDA Received: 09/19/2022; 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 49 KG