MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH RESOLUTION CLIP CLIPPING DEVICE; LIGATOR, ESOPHAGEAL

Model Number UNK177

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the device upn and lot number; therefore, the manufacture date and expiration date are unknown.(b)(4).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 clip device was used during a procedure performed on an unknown date.According to the complainant, the clip did not deploy.No patient complications have been reported as a result of this event.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: RESOLUTION CLIP CLIPPING DEVICE
• Type of Device: LIGATOR, ESOPHAGEAL
• 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: 6751513
• MDR Text Key: 81313001
• Report Number: 3005099803-2017-02278
• Device Sequence Number: 1
• Product Code: MND
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K040148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/11/2017

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: UNK177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 07/28/2017
• 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: N
• Patient Sequence Number: 1