MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPEEDBAND SUPERVIEW SUPER 7; LIGATOR, HEMORRHOIDAL

Model Number M00542251

Device Problem Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).The complaint device was disposed at the facility; however, the photo sent in by the customer showed the ligator head had five bands present which were moved out of their original positions, with one band was caught under other bands, confirming that the bands failed to deploy.It was also noticed that the ligator teeth were bent.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during a band ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands could not be released.Reportedly, after removing the scope from the patient, the bands were found to be overlapping.A photo sent in by the customer confirmed the alleged issue.The procedure was completed with another speedband superview super 7 device.Additionally, there was no difficulty in setting up the device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.

• Brand Name: SPEEDBAND SUPERVIEW SUPER 7
• Type of Device: LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9077777
• MDR Text Key: 159127736
• Report Number: 3005099803-2019-04572
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 08714729201960
• UDI-Public: 08714729201960
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/17/2019

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 Expiration Date: 07/21/2020
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Device Lot Number: 0024143958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2019
• 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