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

Model Number M00542250

Device Problems Positioning Failure (1158); Device Difficult to Setup or Prepare (1487); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: the returned speedband superview super 7 device was analyzed, and a visual evaluation noted that the trip wire was partially rolled in the handle assembly and there was evidence that the trip wire was secured in the handle slot.However, the slack on the trip wire was not removed during the device setup and a crimp was present on the trip wire.The suture was broken with one section was attached to the trip wire loop while the other section was attached to the ligator head.Further analysis noted that the evidence of suture broken was likely to remove the device from the scope.This condition is not considered as an issue of the device.Additionally, the suture hole was slightly torn.The ligator head teeth were damaged and there were five bands attached on the ligator head, confirming the deployment failure.It was noted that the bands were properly placed on the ligator head.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.No damage observed to the handle assembly and no other issues with the device were noted.The reported event was confirmed.Based on the condition and evaluation of the returned device, this failure is likely related to misuse of the device without any design or manufacturing issue.Therefore, the most probable root cause is failure to follow instructions.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 from the information available, this device was not used per the instructions for use (ifu) / product label, as the slack in the trip wire was not removed as mentioned in ifu, and it was removed when rotating the handle, this condition could have affected the overall performance of the device causing an inaccurate deployment of the bands.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during an esophageal varix band ligation with an exploratory endoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the device was unable to deploy off any elastic bands, causing the endoscope to bend with every turn.It was noted that there was an extreme stiffness on the device when the cable length was adjusted during preparation.The procedure was completed with another speedband superview super 7 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 okay.

• Brand Name: SPEEDBAND SUPERVIEW SUPER 7
• Type of Device: LIGATOR, ESOPHAGEAL
• 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: 10661674
• MDR Text Key: 210841314
• Report Number: 3005099803-2020-04520
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 08714729201953
• UDI-Public: 08714729201953
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: Physician
• Type of Report: Initial
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2021
• Device Model Number: M00542250
• Device Catalogue Number: 4225
• Device Lot Number: 0025138674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2020
• 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
• Patient Age: 58 YR