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

Model Number 2261

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 07/07/2022

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 medwatch will be filed.(b)(4).

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in a colonoscopy procedure on (b)(6) 2022.During the procedure, the clip was used to clip the wound.After the handle was pushed, the clip would not detach.The clip was detached after pulling back and forth.The procedure was completed with another clip.There were no patient complications reported as a result to this event.

Manufacturer Narrative

Block h6 (device codes): problem code a15 activation, positioning, or separation problem block h10: investigation results: the resolution clip was analyzed, and a visual evaluation noted that the clip was returned without its over sheath, just with the blue grip attached.The device was returned without the clip assembly, it had evidence of full deployment.Microscope examination was preformed.And it is noted the bushing has hits, and the bushing is deformed.Dimensional analysis was preformed and the dimensions between the hooks of the bushing were measured and two sides found to be out of specification.No other problems with the device were noted.The reported event was determined no problem detected.The device returned without the clip assembly and with evidence of full deployment.Evidence that the clip did release.It is important to mention that the presence of this component is very important for the investigation, as it is directly related to this piece.In addition, the device returned without the over sheath and just with the blue grip attached, but, since there is not enough evidence to clarify the absence of this component, it will be classified as "cause not established".Also, the bushing has hits marks, this probably in the interaction between the yoke and the capsule, in order to make the deploy of the clip.Therefore, this failure will be classified as "adverse event related to procedure".All compiled information on this investigation determines that the most probable cause is "no problem detected".A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to this event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in a colonoscopy procedure on (b)(6) 2022.During the procedure, the clip was used to clip the wound.After the handle was pushed, the clip would not detach.The clip was detached after pulling back and forth.The procedure was completed with another clip.There were no patient complications reported as a result to this event.

• 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 CORPORATION; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15123504
• MDR Text Key: 304294113
• Report Number: 3005099803-2022-04193
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

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 Expiration Date: 08/03/2022
• Device Model Number: 2261
• Device Catalogue Number: 2261
• Device Lot Number: 0024427869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 08/30/2022
• Supplement Dates FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2019
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 55 KG