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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the device lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant reported that the device was not expired.(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 in the stomach during an esophagogastroduodenoscopy (egd) procedure performed on an unknown date.According to the complainant, during the procedure, the clip was difficult to release from the catheter.Eventually the clip was released after some manipulation, and the procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.Attempts to obtain additional patient and procedure information have been unsuccessful.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: 6988473
• MDR Text Key: 91090155
• Report Number: 3005099803-2017-03132
• Device Sequence Number: 1
• Product Code: MND
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• 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
• Date Manufacturer Received: 10/04/2017
• 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: Initial
• Patient Sequence Number: 1