MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number M00521230

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2020 as the event date is unknown.The complainant was unable to report a valid device lot number; therefore, the manufacture date and expiration date are unknown.Health professional was approximated to yes as the initial reporter name and occupation are unknown but the event was reported to have occurred at a health care facility.(b)(4).According to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used during an esophagogastroduodenoscopy (egd) procedure performed on an unknown date.According to the complainant, during the procedure, the clip grasped and locked onto tissue but failed to release from the catheter.Reportedly, multiple attempts were done to detached the clip from catheter, the physician pulled the scope out leading to a perforation in the patient.The procedure was completed with another resolution 360 clip device.The patient was reported to have perforation and hematoma as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: RESOLUTION 360 CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• 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: 11096268
• MDR Text Key: 224409781
• Report Number: 3005099803-2020-06451
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875628
• UDI-Public: 08714729875628
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00521230
• Device Catalogue Number: 54772
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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