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

Model Number M00542251

Device Problems Break (1069); Defective Device (2588); Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 04/18/2022

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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 was intended to be used in the esophagus during a band ligation procedure performed on (b)(6) 2022.During preparation outside the patient, "there was a jam on the reel of the tape ligation kit." upon examination, it was noticed that the trip wire was not installed where it should be, but somewhere else.It was also noticed that part of the handle where the wire should come out was cracked.The procedure was completed with another speedband superview super 7.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: medical device problem code a0401 captures the reportable event of handle broken.Block h10: the returned speedband superview super 7 (handle assembly and ligator head) was analyzed, and a visual evaluation noted that there were five bands attached in the ligator head.The returned handle presented some damages and the trip wire was removed.No any manufacturing or shipping possible defect observed.A functional evaluation was performed by rotating the handle knob.It could be rotated without any problems.The click was audible and indents felt each 180 degrees rotation.No other problems with the device were noted.The reported event of handle broken/won't turn was not confirmed.Upon analysis, it was found that the handle could be rotated without any problems.Therefore, the cause code assigned will be no problem detected.It was also found that the returned ligator head had five bands attached, indicating that the handle was used and rotated.The returned handle presented some damages and the trip wire was removed.Based on the device condition, the observed damages could be related to some extra tension of the trip wire over the handle, or these damages could be related to some interaction of the handle within another support device.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Block h2 (additional information): block d4 (lot number, expiration date) and block h4 (device manufacture date) have been updated based on the additional information received on may 23, 2022.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 was intended to be used in the esophagus during a band ligation procedure performed on (b)(6) 2022.During preparation outside the patient, "there was a jam on the reel of the tape ligation kit." upon examination, it was noticed that the trip wire was not installed where it should be, but somewhere else.It was also noticed that part of the handle where the wire should come out was cracked.The procedure was completed with another speedband superview super 7.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 14402831
• MDR Text Key: 292997181
• Report Number: 3005099803-2022-02357
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 08714729201960
• UDI-Public: 08714729201960
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2022
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Device Lot Number: 0028223544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2021
• 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