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

Model Number M00542253

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Received one speedband superview super 7 with the irrigation catheter for analysis.A visual examination of the suture found it was broken with one portion attached to the ligator head and the other portion was attached to the trip wire loop.There was no damaged found to the ligator head and looked under in good condition.It was noticed that the ligator head teeth were not bent.It was observed that the bands were not present on the ligator head, indicating the device was fully deployed.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.A second functional evaluation was performed by attaching the irrigation catheter to the irrigation valve; the water was injected and the device was able to irrigate without any issues.The investigation concluded that, customer maneuvering or handling during the use of the device can lead to find the suture cut, however, at this point it is uncertain how the damages was caused, there is a lack of objective evidence or descriptive conditions of the event required to determine a definitive root cause of the event.The investigation findings and all information available do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is cause not established.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 during a procedure performed on an unknown date.It was found that the suture was broken.No patient complications have been reported due to this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 9379236
• MDR Text Key: 189740242
• Report Number: 3005099803-2019-05675
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 08714729504832
• UDI-Public: 08714729504832
• Combination Product (y/n): N
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2020
• Device Model Number: M00542253
• Device Catalogue Number: 4225
• Device Lot Number: 0023991267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Date Manufacturer Received: 11/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1