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

Model Number M00542251

Device Problems Premature Activation (1484); Failure to Fire (2610)

Patient Problem No Code Available (3191)

Event Date 07/25/2019

Event Type  Injury  

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 a speedband superview super 7 device was used during an esophageal varicose vein ligation (evvl) procedure performed on (b)(6) 2019.According to the complainant, the patient had been initially admitted to the hospital on (b)(6) 2019.The exact reason for initial hospitalization was not reported.On (b)(6) 2019 during the evvl procedure, the fifth, sixth and seventh bands could not be deployed.Reportedly, the physician withdrew the device from the patient and noted that the seventh band was stuck under the fifth and sixth bands.The procedure was completed with this device and there were no patient complications reported as a result of this event.It was also noted that there was no difficulty in setting up the device.The patient's condition after the procedure was reported to be stable.Due to the evvl procedure taking longer than expected, the patient's hospitalization was prolonged.The patient's exact discharge date was not reported, however, it was reported the patient was discharged after (b)(6) 2019.

• 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
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8932495
• MDR Text Key: 155634465
• Report Number: 3005099803-2019-04236
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 08714729201960
• UDI-Public: 08714729201960
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Physician
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2019
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Device Lot Number: 0023034534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2018
• 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: 50 YR
• Patient Weight: 170