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 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Second reported fax number: (b)(6).(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 a band ligation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, resistance was felt when the first elastic band was deployed.Another attempt was made to deploy the band, but the band failed to deploy.Reportedly, the scope was removed from the patient, and the procedure was completed with another speedband superview super 7 device.Additionally, there was no difficulty experienced upon 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 okay.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during a band ligation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, resistance was felt when the first elastic band was deployed.Another attempt was made to deploy the band, but the band failed to deploy.Reportedly, the scope was removed from the patient, and the procedure was completed with another speedband superview super 7 device.Additionally, there was no difficulty experienced upon 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 okay.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block e1: second reported fax number: (b)(6) block h6: device code 2610 for the reportable issue of bands failed to deploy.Block h10: investigation results the returned speedband superview super 7 device and the ligator head were analyzed.A visual evaluation noted that the crimp was present on the trip wire.The tripwire was found mechanically cut with both sections returned and it was noticed that one section was rolled around the spool of the handle.It was noted that the trip wire was not secured on the handle assembly slot, as there were evidence of drag marks.Additionally, there were seven knots found on the suture and the suture was tied to the tripwire distal loop, but was not connected to the ligator head.It was possible to observe that the ligator head found seven bands present and all of the bands are attached to their original positions.One of the ligator teeth was bent.The suture hole was deformed, indicating an excessive tension was applied during the procedure.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.No visible issue was noted on the handle assembly.No other issues with the device were noted.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 could have contributed to the reported issues.There was evidence that the tripwire was cut in order to remove the device from the scope.This condition is not considered as an issue of the device.The reported event was confirmed.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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.

• 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: 9801703
• MDR Text Key: 190826372
• Report Number: 3005099803-2020-00748
• 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: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2020
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Device Lot Number: 0024731989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1