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

Model Number M00542253

Device Problems Use of Device Problem (1670); Failure to Fire (2610); Activation, Positioning or Separation Problem (2906)

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

Event Date 09/14/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 was used in the esophagus during a gastroesophageal varices ligation procedure performed on (b)(6) 2022.During the procedure, the first two bands were deployed successfully on active variceal bleeding, and the bleeding was stopped.Since there were still bands left, it was decided to deploy on non bleeding varices as a prophylaxis.When the handle was rotated, the click sound was not heard and the bands did not deploy.It was attempted three times but the bands did not deploy.The endoscope was removed and it was found that the bands were entangled in the ligator head.The procedure was completed with this device.It was noted that there was no difficulty 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.Note: a photo of the complaint device outside the patient was provided by the customer and shows the ligator housing with four bands attached, and some of them were moved and overlapped.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Block h6: medical device problem code a050501 captures the reportable event of bands unable to deploy.Block d4 (lot number, expiration date) and block h4 (device manufacture date) have been updated based on the additional information (batch/lot number) received on november 19, 2022.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 was used in the esophagus during a gastroesophageal varices ligation procedure performed on (b)(6) 2022.During the procedure, the first two bands were deployed successfully on active variceal bleeding, and the bleeding was stopped.Since there were still bands left, it was decided to deploy on non bleeding varices as a prophylaxis.When the handle was rotated, the click sound was not heard and the bands did not deploy.It was attempted three times but the bands did not deploy.The endoscope was removed and it was found that the bands were entangled in the ligator head.The procedure was completed with this device.It was noted that there was no difficulty 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.Note: a photo of the complaint device outside the patient was provided by the customer and shows the ligator housing with four bands attached, and some of them were moved and overlapped.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 was used in the esophagus during a gastroesophageal varices ligation procedure performed on (b)(6) 2022.During the procedure, the first two bands were deployed successfully on active variceal bleeding, and the bleeding was stopped.Since there were still bands left, it was decided to deploy on non bleeding varices as a prophylaxis.When the handle was rotated, the click sound was not heard and the bands did not deploy.It was attempted three times but the bands did not deploy.The endoscope was removed and it was found that the bands were entangled in the ligator head.The procedure was completed with this device.It was noted that there was no difficulty 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.Note: a photo of the complaint device outside the patient was provided by the customer and shows the ligator housing with four bands attached, and some of them were moved and overlapped.

Manufacturer Narrative

Block h6: medical device problem code a050501 captures the reportable event of bands unable to deploy.Block h10: the returned speedband superview super 7 (ligator head only) was analyzed, and a visual evaluation noted that there were six bands attached in the ligator head, and some of them were moved and overlapped.The device was observed under magnification, and it was found that the ligator head teeth were bent/damaged.The suture hole was in good condition.One band was cracked/damaged.No other problems with the device were noted.The reported event of bands unable to deploy was confirmed.Upon analysis, it was found that the ligator head teeth were bent/damaged, the bands on the ligator head were moved, and one band was cracked/damaged.These suggest that the device could not deploy.These conditions could have been generated due to excess of tension applied when trying to make the deployment of the bands.This situation moved the bands from their place as if twisting them even causing the band to crack, which clearly indicated inability of the device to deploy the bands.It is possible that the functionality of the device has been affected in some way; perhaps an excess of force, manipulation, the technique used, or the patient's anatomical conditions could have contributed to the reported event.The most probable root cause of this complaint is adverse event related to procedure.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu) as the speedband superview super 7 device was used after the expiration date; however, per the speedband superview super 7 multiple band ligator instructions for use, "rotate inventory so that products are used prior to the expiration date on package label.".

Manufacturer Narrative

Block h6: medical device problem code a050501 captures the reportable event of bands unable to deploy.Block h11 (correction): block d4 (lot number, expiration date), block h4 (device manufacture date), and block h10 have been updated.The device evaluation has been transferred to report number 3005099803-2022-05656.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 was used in the esophagus during a gastroesophageal varices ligation procedure performed on (b)(6) 2022.During the procedure, the first two bands were deployed successfully on active variceal bleeding, and the bleeding was stopped.Since there were still bands left, it was decided to deploy on non bleeding varices as a prophylaxis.When the handle was rotated, the click sound was not heard and the bands did not deploy.It was attempted three times but the bands did not deploy.The endoscope was removed and it was found that the bands were entangled in the ligator head.The procedure was completed with this device.It was noted that there was no difficulty 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.Note: a photo of the complaint device outside the patient was provided by the customer and shows the ligator housing with four bands attached, and some of them were moved and overlapped.

• 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: 15572445
• MDR Text Key: 306736101
• Report Number: 3005099803-2022-05655
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 08714729504832
• UDI-Public: 08714729504832
• Combination Product (y/n): N
• Reporter Country Code: LH
• 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,Followup,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2022
• Device Model Number: M00542253
• Device Catalogue Number: 4225-40
• Device Lot Number: 0028467081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 102 KG