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

Model Number M00542253

Device Problem Misfire (2532)

Patient Problems Hemorrhage/Bleeding (1888); Hypovolemia (2243)

Event Date 01/13/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2022.During the procedure, it was noted that there was no difficulty experienced upon setting up the device; however, when the physician deployed the first band, it came off with such a force that it rolled off the cap, broke the suction, and was sucked up into the endoscope.This also happened with the second and third bands when the physician tried to deploy the device.There was an active spurting of blood.The physician used a second speedband superview super 7 and it successfully deployed five bands, which successfully stopped the bleeding.On the same day, the patient went to the hospital with no bleeding, just for observation.Another egd was performed diagnostically to verify that the bands were still in place and that there was no bleeding.The patient was given transfusions and treatment for hypovolemia.The patient was discharged on (b)(6) 2022.

• 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: 13635618
• MDR Text Key: 286344865
• Report Number: 3005099803-2022-01021
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 08714729504832
• UDI-Public: 08714729504832
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2022
• Device Model Number: M00542253
• Device Catalogue Number: 4225-40
• Device Lot Number: 0027737218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR