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

Model Number M00542250

Device Problems Component Missing (2306); Material Integrity Problem (2978)

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

Event Date 09/14/2022

Event Type  malfunction  

Manufacturer Narrative

(report source): foreign: west bank gaza strip (palestinian territories).(b)(4).

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 was intended to be used in the esophagus during an endoscopic ligation of esophageal varices procedure performed on (b)(6) 2022.During preparation, it was noticed that the bands were incomplete, only fours bands were attached in the ligator head instead of seven.The procedure was completed with another speedband superview super 7.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.A photo of the complaint device outside the patient was provided by the customer and shows the only four bands attached in the ligator head and the bands were moved from their position.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 was intended to be used in the esophagus during an endoscopic ligation of esophageal varices procedure performed on (b)(6) 2022.During preparation, it was noticed that the bands were incomplete, only fours bands were attached in the ligator head instead of seven.The procedure was completed with another speedband superview super 7.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 only four bands attached in the ligator head and the bands were moved from their position.

Manufacturer Narrative

Block g2 (report source): foreign: (b)(6) (palestinian territories).Block h6: medical device problem code a04 captures the reportable event of bands moved from their position.Block h10: the speedband superview super 7 was not returned; however, photos of the complaint device were provided by the complainant.Per media analysis, the first photo showed a ligator head with four bands overlapped and moved from their position which suggest inability of the device to deploy bands and it also showed a cracked band.No other problems with the device were noted from the photo the reported event of bands damaged/defective was confirmed.Upon media analysis, it was observed that the band was cracked, and some bands overlapped and moved in the ligator; however, the device was not returned for analysis and a deep inspection of the device could not be performed in order to determine the most possible root cause of the problem.The most probable root cause of this complaint is cause not established.

Manufacturer Narrative

Block g2 (report source): foreign: west bank gaza strip (palestinian territories).Block h6: medical device problem code a04 captures the reportable event of bands moved from their position.Block h10: the returned speedband superview super 7 (ligator housing only) was analyzed, and a visual evaluation noted that the returned ligator housing had four bands attached and some of them were moved and overlapped, and some bands were cracked/damaged.The ligator housing teeth were bent/damaged.These findings were consistent with the findings per media analysis.The suture thread was broken, possibly during the device removal.The suture hole of the ligator housing was in good condition.No other problems with the device were noted.The reported event of bands damaged/defective was confirmed.Upon analysis, it was found that some bands attached in the ligator head were moved and overlapped, and some bands were cracked/damaged.The reported problem packaging - component missing cannot be confirmed because there is not enough objective evidence to determine that the customer received the product with a missing component.It was also found that the the ligator housing teeth were bent.These conditions could have been generated due to an excess of tension applied to the suture moving the bands from their place as if twisting them causing the overlap and even the cracking of some bands.So, it is possible that inability to deploy the bands occurred.The returned suture thread was broken, as there was no information about a rupture of the suture thread, it is possible that the suture was broken at the time of removing the device.The most probable root cause of this complaint is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 was intended to be used in the esophagus during an endoscopic ligation of esophageal varices procedure performed on (b)(6) 2022.During preparation, it was noticed that the bands were incomplete, only fours bands were attached in the ligator head instead of seven.The procedure was completed with another speedband superview super 7.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 only four bands attached in the ligator head and the bands were moved from their position.

• 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: 15542050
• MDR Text Key: 306436181
• Report Number: 3005099803-2022-05742
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 08714729201953
• UDI-Public: 08714729201953
• Combination Product (y/n): N
• Reporter Country Code: WE
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2023
• Device Model Number: M00542250
• Device Catalogue Number: 4225
• Device Lot Number: 0028699065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2022
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 74 KG