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

Model Number M00542251

Device Problems Misfire (2532); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2014

Event Type  malfunction  

Event Description

Note: this report pertains to one of four devices used during the same procedure.Refer to manufacturer report # 3005099803-2014-01943, manufacturer report # 3005099803-2014-01944, manufacturer report # 3005099803-2014-01945 and manufacturer report # 3005099803-2014-01955 for the associated device information.It was reported to boston scientific corporation that four speedband superview super7 devices were used during an upper endoscopy procedure performed on (b)(6) 2014.Reportedly the varices were located at the esophagogastric junction.According to the complainant, during the procedure, the first speedband superview super7 was able to release the bands but they missed the target area.The physician then proceeded to use the second and third speedband superview super7 devices but the same problem occurred.When the fourth speedband device was attempted to be used, the tripwire broke.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patients' condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Reported event of bands misfired.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: SPEEDBAND SUPERVIEW SUPER 7?
• Type of Device: LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• 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: 3808392
• MDR Text Key: 4371910
• Report Number: 3005099803-2014-01943
• 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: Physician
• Type of Report: Initial
• Report Date: 04/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2014
• 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