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

Model Number M00542251

Device Problems Break (1069); Use of Device Problem (1670); Suction Problem (2170)

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

Event Date 11/22/2021

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

Note: this report pertains to the second of two speedband superview super 7 devices used in the same procedure.It was reported to boston scientific corporation that two speedband superview super 7 devices were used in the cardia during an internal hemorrhoidal ligation procedure performed on (b)(6) 2021.During the preparation, it was noticed that the suction was not enough and a crack was also observed at the tail end of the device which caused an air leakage.The same issue happened with the second speedband superview super 7 device, and 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.Additionally, it was noted that the device was going to be expired on september 28, 2021, but the device was used during a procedure on (b)(6) 2021.Note: according to the complainant, the speedband superview super 7 device was used in the cardia.However, per the speedband superview super 7 multiple band ligator instructions for use, the device is not intended for ligation of esophageal varices below the gastroesophageal junction.

Manufacturer Narrative

Block h6: medical device code a0401 captures the reportable event of ligator housing was cracked.Block h10: investigation results the returned speedband superview super 7 device was analyzed, and a visual evaluation noted that only the handle assembly was returned and the ligator head was not returned with the device.It was also noted that the the trip wire was secured and the slack was correctly taken up.The suture thread was attached to the distal loop and it was intact.Further examination shows that the handle did not present any problems.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 problems with the device were noted.The reported event was not confirmed.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A review of the instructions for use (ifu) and product labeling was completed and revealed evidence of device misuse or that the device was used in a manner inconsistent with the labeled indications.It was reported that the device was used in the cardia which is not an anatomy indicated in the ifu.Per the ifu, "the speedband superview super 7 multiple band ligator is not intended for ligation of esophageal varices below the gastroesophageal junction".Additionally, the device was found to be used in a procedure after the expiration date for this lot number.

Event Description

Note: this report pertains to the second of two speedband superview super 7 devices used in the same procedure.It was reported to boston scientific corporation that two speedband superview super 7 devices were used in the cardia during an internal hemorrhoidal ligation procedure performed on (b)(6)2021.During the preparation, it was noticed that the suction was not enough and a crack was also observed at the tail end of the device which caused an air leakage.The same issue happened with the second speedband superview super 7 device, and 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.Additionally, it was noted that the device was going to be expired on september 28, 2021, but the device was used during a procedure on (b)(6), 2021.Note: according to the complainant, the speedband superview super 7 device was used in the cardia.However, per the speedband superview super 7 multiple band ligator instructions for use, the device is not intended for ligation of esophageal varices below the gastroesophageal junction.

• 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: 13020618
• MDR Text Key: 285614267
• Report Number: 3005099803-2021-07830
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 08714729201960
• UDI-Public: 08714729201960
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: M00542251
• Device Catalogue Number: 4225
• Device Lot Number: 0026088546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2020
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 57 KG