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

Model Number M00542253

Device Problem Failure to Fire (2610)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); No Code Available (3191)

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

Patient's weight: (b)(6).(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that two speedband superview super 7 devices were used in the esophagus during an esophagogastroduodenoscopy (egd) with variceal banding procedure performed on (b)(6) 2020.During the procedure, the speedband device was used in an attempt to stop the bleeding of the esophageal varices.The first two bands successfully deployed, and another two bands were attempted to be deployed, but the bands failed to deploy and blocked the ligator cap visualization.The scope was removed from the patient.A second speedband device was used; however, the same issue occurred.The physician then used a hemospray to stop the bleed.A pediatric esophagogastroduodenoscopy (egd) scope was also used to remove the blood.The patient was then intubated and was brought to the intensive care unit (icu).The physician assessed that the "bands lacerated the varices during the procure." the patient has since been discharged from the icu, however the exact discharge date was not reported.The patient's current condition was reported to be stable.

• Brand Name: SPEEDBAND SUPERVIEW SUPER 7
• Type of Device: LIGATOR, HEMORRHOIDAL
• 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: 9687656
• MDR Text Key: 178525441
• Report Number: 3005099803-2020-00343
• Device Sequence Number: 1
• Product Code: FHN
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2020
• Device Model Number: M00542253
• Device Catalogue Number: 4225-40
• Device Lot Number: 0024739121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2019
• 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): Required Intervention
• Patient Age: 67 YR