MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER SPEEDBAND SUPERVIEW SUPER 7?; LIGATOR, HEMORRHOIDAL

Model Number M00542251

Device Problem Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation on (b)(6), 2013 that a speedband superview super 7 was used in the esophagus during an esophagogastroduodenoscopy procedure.According to the complainant, during the procedure, the band detached from the scope when it was deployed.The procedure was completed with another of the same device.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 fine.Despite numerous attempts boston scientific has been unable obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available a supplemental report will be submitted.

Manufacturer Narrative

Date of this report: although the exact event date is unknown it was reported to be between (b)(6), 2013.Additional device info: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, it was reported that the device was used prior to the expiration date.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 mdr will be filed.At this time, we are unable to determine the relationship between the device and the cause for the event.

• Brand Name: SPEEDBAND SUPERVIEW SUPER 7?
• Type of Device: LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3558291
• MDR Text Key: 4077376
• Report Number: 3005099803-2014-00054
• Device Sequence Number: 1
• Product Code: FHN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2013
• 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