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

Model Number M00542251

Device Problem Premature Activation (1484)

Patient Problem Tissue Damage (2104)

Event Date 02/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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 trans-oesophageal ligation of oesophageal varices (lvo) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the handle was rotated in order to deploy an elastic band; however, two elastic bands were able to deploy and happened several times on the same device.The speedband device was removed from the patient, and the second speedband device was used, but the same issue occurred.Reportedly, the deployment failure led to a superficial lesion of the esophageal mucosa which did not require any treatment.The procedure was completed with another speedband superview super 7 device.Additionally, there was no difficulty experienced upon setting up the devices.The patient condition at the conclusion of the procedure was reported to be good.

• 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: 9868254
• MDR Text Key: 191289044
• Report Number: 3005099803-2020-01266
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 08714729201960
• UDI-Public: 08714729201960
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2020
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Device Lot Number: 0024930890
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2019
• 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