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

Model Number M00542253

Device Problems Positioning Failure (1158); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2020

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 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, the bands got stuck and did not release.The procedure was completed with another speedband superview super 7 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 a band ligation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the bands got stuck and did not release.The procedure was completed with another speedband superview super 7 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.***additional information received on july 08, 2020*** it was reported that there was no difficulty experienced upon setting up the device.

Manufacturer Narrative

Block h6: device code 2610 captures the reportable issue of bands failed to deploy.Block h10: investigation results the returned speedband superview super 7 was analyzed, and a visual evaluation noted that the trip wire was partially rolled in the handle assembly; however, it was observed that it did not have an evidence that the trip wire was secured in the handle slot.A crimp was present on the tripwire.It was possible to observe that the suture was attached to the tripwire loop, there were seven knots, and no issues were found.Additionally, the ligator head had two bands attached to it and the bands were moved out of their original positions with some bands damaged.It was noticed that the ligator head teeth were bent.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.No damage observed to the handle assembly and no other issues with the device were noted.The reported event was confirmed.Based on the condition and evaluation of the returned device, this failure is likely related to misuse of the device without any design or manufacturing issue.Therefore, the most probable root cause is failure to follow instructions.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 not used per the directions for use (dfu)/product label, as the slack was not removed correctly and the trip wire was not secured in the handle slot indicated in the step 4, 7 and 8.Additional information: b5.

• Brand Name: SPEEDBAND SUPERVIEW SUPER 7
• Type of Device: LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10219906
• MDR Text Key: 197187333
• Report Number: 3005099803-2020-02567
• Device Sequence Number: 1
• Product Code: MND
• 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: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2020
• Device Model Number: M00542253
• Device Catalogue Number: 4225-40
• Device Lot Number: 0024819659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1