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

Model Number M00542253

Device Problems Use of Device Problem (1670); Failure to Fire (2610); Device-Device Incompatibility (2919); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2019

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(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 lower esophagus and stomach during an esophagogastroduodenoscopy (egd) with endoscopic mucosal resection (emr) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician attempted passing snare through the working channel while the speedband device was still in the scope but failed to exit out of the scope.The scope was removed from the patient and the staff was able to pass the snare through the speedband ligator cap via adjusting articulation of scope head.The scope was then re-inserted into the patient; however, when the handle was turned, the bands would not deploy even after multiple attempts.Reportedly, the scope was removed again with the device, and the procedure was completed with a different 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 fine.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used in the lower esophagus and stomach during an esophagogastroduodenoscopy (egd) with endoscopic mucosal resection (emr) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician attempted passing snare through the working channel while the speedband device was still in the scope but failed to exit out of the scope.The scope was removed from the patient and the staff was able to pass the snare through the speedband ligator cap via adjusting articulation of scope head.The scope was then re-inserted into the patient; however, when the handle was turned, the bands would not deploy even after multiple attempts.Reportedly, the scope was removed again with the device, and the procedure was completed with a different 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 fine.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Investigation result only the ligator head was returned for analysis.A visual examination of the component found four bands present and were moved out of their original position.It was also noticed that the ligator teeth were bent.Based on the evaluation of the returned ligator head, 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 which could have contributed with 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.A labeling review was performed and from the information available, this device was not used per the directions for use (dfu)/product label; the dfu does not indicate on any section or procedure step that the snare can or requires to be passed/inserted into the working channel of the scope when the speedband device was already loaded on it.

• 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: 8332799
• MDR Text Key: 136009746
• Report Number: 3005099803-2019-00568
• 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: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2019
• Device Model Number: M00542253
• Device Catalogue Number: 4225-40
• Device Lot Number: 0022529663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1