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

Model Number M00542253

Device Problem Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2019 as the event date is unknown.(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 during a procedure performed on an unknown date.According to the complainant, during the procedure, both speedband devices did not deploy.The procedure was completed with a third speedband superview super 7 device.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that two speedband superview super 7 devices were used during a procedure performed on an unknown date.According to the complainant, during the procedure, both speedband devices did not deploy.The procedure was completed with a third speedband superview super 7 device.There were no patient complications reported as a result of this event.***additional information received on (b)(6) 2019*** it was reported that the procedure performed was esophagogastroduodenoscopy with esophageal varices banding.The first speedband device was attempted to be deployed; however, it did not deploy after several attempts.Then, the second speedband device was able to successfully deploy three elastic bands, but stopped deploying on the fourth band.

Manufacturer Narrative

Block b3: date of event was approximated to (b)(6) 2019 as the event date was reported to have occurred on (b)(6) 2019.Block h6: problem code 2610 for the reportable issue of bands failed to deploy.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned".Block h10: 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.Additional information: a3 (sex), b3, b5 (describe event or problem) fda registration #: (b)(4).

• Brand Name: SPEEDBAND SUPERVIEW SUPER 7
• Type of Device: LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9438855
• MDR Text Key: 189767607
• Report Number: 3005099803-2019-05973
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 08714729504832
• UDI-Public: 08714729504832
• Combination Product (y/n): N
• PMA/PMN Number: K020824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2020
• Device Model Number: M00542253
• Device Catalogue Number: 4225-40
• Device Lot Number: 0024234603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1