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

Model Number M00521230

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2018

Event Type  Injury  

Manufacturer Narrative

It was reported the patient is over 18 years.The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.It was reported the device was not used past its expiry date.Problem code relates to the reported issue of hypotube detached.According to the complainant, the suspect device has been disposed and 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 in a colonoscopy procedure on (b)(6) 2018.According to the complainant, during the procedure, the hypotube detached into the patient, and was retrieved using grasping forceps.The procedure was completed at this time.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used in a colonoscopy procedure on (b)(6) 2018.According to the complainant, during the procedure, the hypotube detached into the patient, and was retrieved using grasping forceps.The procedure was completed at this time.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: RESOLUTION 360¿ CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7278329
• MDR Text Key: 100387086
• Report Number: 3005099803-2018-00449
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875628
• UDI-Public: 08714729875628
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K151802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00521230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• 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
• Patient Outcome(s): Required Intervention