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

Model Number M00542251

Device Problems Suction Problem (2170); Human-Device Interface Problem (2949)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a22 captures the reportable event of bands fell off the varix.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 was used in the esophagus during a procedure to treat esophageal varices performed on (b)(6) 2023.During the procedure, the band fell off the varix as it was noticed that the ligator was not able to suction the varix in full.The procedure was completed with another speedband superview super 7.It was noted that no difficulty was experienced upon setting up the device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 was used in the esophagus during a procedure to treat esophageal varices performed on (b)(6) 2023.During the procedure, the band fell off the varix as it was noticed that the ligator was not able to suction the varix in full.The procedure was completed with another speedband superview super 7.It was noted that no difficulty was experienced upon setting up the device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a22 captures the reportable event of bands fell off the varix.Block h10: the returned speedband superview super 7 was analyzed, and a visual evaluation noted that the returned ligator housing had three bands attached.The ligator housing teeth were in good condition, and the suture was broken.The handle slot had evidence that the trip wire was secured.No other problems with the device were noted.The reported event of bands fell off the varix cannot be confirmed.Upon analysis, it was found that the ligator housing had three bands attached, and the suture was broken.The device (ligator housing) could have been placed incorrectly onto the varix when it was needed to suction it in order to use the bands on it, making the bands not catch the varix as it should.The suction problem could also have happened if the varix that was being treated was not grabbed correctly by the ligator housing; however, the suction part of the procedure is not something that the device does by itself, and this would only be seen on the procedure.The bands not being deployed might have to do with the technique used by the physician or the way the device is being handled when trying to deploy the bands with the handle.The returned suture thread was broken, since there is no information about a rupture of the suture, it is possible that the suture was broken at the time of removing the device.Therefore, the most probable root cause of this complaint is adverse event related to procedure.Block h11 (correction): block e1 (initial reporter address 2) has been updated.

• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18532816
• MDR Text Key: 333503211
• Report Number: 3005099803-2023-07191
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 08714729201960
• UDI-Public: 08714729201960
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Device Lot Number: 0031799524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2023
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 68 KG