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

Model Number M00542251

Device Problem Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(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 in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the third band was attempted to be deployed; however, the band would not continue to deploy.Reportedly, the physician removed the device from the patient and the procedure was completed with another speedband superview super 7 device.Additionally, it was noted that there was no difficulty when setting up the device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the third band was attempted to be deployed; however, the band would not continue to deploy.Reportedly, the physician removed the device from the patient and the procedure was completed with another speedband superview super 7 device.Additionally, it was noted that there was no difficulty when setting up the device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Initial reporter address 1: (b)(6).Problem code 2610 for the reportable issue of bands failed to deploy.Investigation results: only the ligator head was returned for analysis.A visual examination of the ligator head found three bands present.It was also noticed that the ligator head were bent.Based on the evaluation of the returned complaint device, these failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.It is most likely that the ligator head teeth were damaged due to handling and manipulation of the device during the procedure.Once the ligator head teeth are damaged, the suture can be detached from its position on the ligator head and this condition could have impacted the bands deployment activity and which could have contributed to the reported issues.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• 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: 9199145
• MDR Text Key: 177549630
• Report Number: 3005099803-2019-05073
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 08714729201960
• UDI-Public: 08714729201960
• Combination Product (y/n): N
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2020
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Device Lot Number: 0023615811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 6 MO
• Patient Weight: 64