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

Model Number M00542250

Device Problems Suction Problem (2170); Failure to Fire (2610)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch 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 esophageal elastic ligature procedure performed on (b)(6) 2021.During the procedure, the bands were not able to deploy.Additionally, it was noted that the suction was insufficient.It was reported that the device was removed and the procedure was not completed due to this event.A photo submitted by the customer shows that the seven bands were still attached to the ligator head; however, four of the bands were moved out of their original position.No patient complications have been reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during an esophageal elastic ligature procedure performed on (b)(6), 2021.During the procedure, the bands were not able to deploy.Additionally, it was noted that the suction was insufficient.It was reported that the device was removed and the procedure was not completed due to this event.A photo submitted by the customer shows that the seven bands were still attached to the ligator head; however, four of the bands were moved out of their original position.No patient complications have been reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: medical device code a050501 captures the reportable issue of bands unable to deploy.Block h10: investigation results the complaint device was not returned; however, the customer provided some photos of the device.The photos show the ligator head with all seven bands still attached; however, some of the bands were moved out from their original positions and one band was caught under other bands indicating that the device unable to deploy.Additionally, it was possible to observe some damaged to the ligator head teeth.The reported event of failure to deploy bands is confirmed.The reported suction problem could not be confirmed as the device was not returned.With all the information available, it was determined that the tension applied to the ligator head by the suture during the band deployment could have bent the teeth on the component.This can cause the suture to move from its original position leading to an improper deployment of the bands.Therefore, the most probable root cause of this event is adverse event related to procedure.A device history record (dhr) review was performed and confirmed that this device met all material, assembly, and performance specifications.

Manufacturer Narrative

Block h6: medical device code a050501 captures the reportable issue of bands unable to deploy.Block h10: investigation results one speedband superview super 7 was returned for analysis (handle assembly and ligator head).The returned speedband superview super 7 device was analyzed, and a visual evaluation noted that the ligator head was returned with no bands attached to it.Additionally, four detached bands were returned with the device.The trip wire was removed from the handle assembly and the handle did not have marks that the trip wire was previously secured.The ligator head teeth were damaged (bent).A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard, and indents were felt.No other problems with the device were noted.A media inspection of the photos provided by the customer was also performed.The photos showed the ligator head with all seven bands attached; however, some bands were moved from their original positions and one band was caught under other bands, confirming the reported event.It was also observed that some of the ligator head teeth were damaged (bent).The reported event was confirmed.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu).A visual evaluation identified that the trip wire was not secured in the handle slot.Failure to follow this step could have caused the trip wire to slip through the handle assembly and can cause more tension on the device, bending the ligator head teeth and affect the bands deployment activity.Taking all available information into consideration, the most probable root cause is failure to follow instructions, since it was determined that the problems traced to the user not following the manufacturer's instructions.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during an esophageal elastic ligature procedure performed on (b)(6) 2021.During the procedure, the bands were not able to deploy.Additionally, it was noted that the suction was insufficient.It was reported that the device was removed and the procedure was not completed due to this event.A photo submitted by the customer shows that the seven bands were still attached to the ligator head; however, four of the bands were moved out of their original position.No patient complications have been reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: SPEEDBAND SUPERVIEW SUPER 7
• Type of Device: LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12633223
• MDR Text Key: 276418708
• Report Number: 3005099803-2021-05317
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 08714729201953
• UDI-Public: 08714729201953
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: M00542250
• Device Catalogue Number: 4225
• Device Lot Number: 0027071873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male