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

Model Number M00542251

Device Problems Misfire (2532); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2018

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).Investigation result: received one speedband device with the velcro strap and the ligator head for analysis.A visual examination of the ligator head found five bands present with some of the bands were moved out of their positions and some were caught under other bands.It was noticed that the ligator head teeth were bent.The suture was intact and attached to the trip wire loop and ligator head.Further examination of the trip wire found bent in several locations and was secured in the handle assembly slot when received.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.No issue was noted with the handle assembly and the velcro strap.Based on the evaluation of the returned device, these failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.It is most likely that the trip wire was bent and the ligator head teeth were damaged due to handling and manipulation of the device during procedure.Once the ligator head teeth are damaged, the suture can be detached from its position on the ligator head and this condition could have impacted the bands deployment activity, moving bands without being deployed, and contributing to the reported issues.Based on the information available and the analysis performed, it was concluded that the investigation conclusion code of this event is cause traced to component failure, since expected or random component failure without any design or manufacturing issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and no anomalies were found.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the bands were intertwined on each other.The procedure was completed with another speedband superview super 7 device.Additionally, it was noted that there was no difficulty when setting up the device.There were no patient complications reported as a result of this event.Investigation results showed that the bands failed to deploy and the ligator head teeth were damaged; this is now an mdr reportable event.

• 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: 7934586
• MDR Text Key: 122816516
• Report Number: 3005099803-2018-60684
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 08714729201960
• UDI-Public: 08714729201960
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K EXEMPT
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2019
• Device Model Number: M00542251
• Device Catalogue Number: 54145
• Device Lot Number: 0021713091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• 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