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

Model Number M00542253

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2019

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 a speedband superview super 7 device was used in the esophagus during an endoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, any of the elastic bands would not deploy.Reportedly, the device was withdrawn from the patient and the seven bands deployed at the same time.The procedure was completed with another speedband superview super 7 device.There were no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 a speedboat superview super 7 device was used in the esophagus during an endoscopy procedure performed on (b)(6)2019.According to the complainant, during the procedure, any of the elastic bands would not deploy.Reportedly, the device was withdrawn from the patient and the seven bands deployed at the same time.The procedure was completed with another speedband superview super 7 device.There were no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 there was no difficulty experienced upon setting up the device.

Manufacturer Narrative

Problem code 2610 for the reportable issue of bands failed to deploy.Problem code 1484 relates to the reportable issue of bands prematurely deployed.Investigation results received one speedband superview super 7 with the ligator head for analysis.It was noticed that the tripwire was partially rolled and was secured in the handle assembly slot when received.A visual examination of the ligator head found all bands had been deployed.It was noted that the ligator head teeth were bent.The suture was found to be intact and attached to the trip wire loop.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.No issue was noted with the handle assembly.Based on the evaluation of the returned 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, moving bands without being deployed or moving several bands with one rotation of the handle, and contributing 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.Additional information: b5 and e1 (initial reporter first name).

• 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: 9385890
• MDR Text Key: 189740823
• Report Number: 3005099803-2019-05722
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 08714729504832
• UDI-Public: 08714729504832
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2020
• Device Model Number: M00542253
• Device Catalogue Number: 4225-40
• Device Lot Number: 0024575290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1