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

Model Number M00542251

Device Problems Use of Device Problem (1670); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2019

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 esophageal and gastric varices during an endoscopic variceal band ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands were twisted together and could not be released normally.There was no difficulty in setting up the device.The procedure was completed with another speedband superview super 7 device.The physician also reported that the ligator shrink wrap on the device was removed earlier in the setup process than as instructed in the device directions for use.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

Block h6: problem code 2610 relates to the reportable issue of bands failed to deploy.Block h10: investigation results: only the ligator head was returned for analysis.A visual examination of the ligator head found all bands present which were moved out of their original positions with some bands were caught under the other bands.It was also noticed that the ligator teeth were bent.The other components were not returned with the device.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 ligator shrink wrap on the device was removed prior to the setup process, and it is the step number 10 in the dfu.Based on the condition and evaluation of the returned device, the most probable root cause is failure to follow instructions since the problem was traced to the user not following the manufacturer instructions.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophageal and gastric varices during an endoscopic variceal band ligation (evl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands were twisted together and could not be released normally.There was no difficulty in setting up the device.The procedure was completed with another speedband superview super 7 device.The physician also reported that the ligator shrink wrap on the device was removed earlier in the setup process than as instructed in the device directions for use.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.

• 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: 8873738
• MDR Text Key: 153669906
• Report Number: 3005099803-2019-04009
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2020
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Device Lot Number: 0023578663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 60