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

Model Number M00542253

Device Problems Defective Device (2588); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the band would not load and the cord would not thread correctly.Attempts to obtain additional information regarding this event have been unsuccessful to date. should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Block h6: conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned".Block h10: the device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a speedband superview super 7 device was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the band would not load and the cord would not thread correctly.Attempts to obtain additional information regarding this event have been unsuccessful to date. should additional relevant details become available, a supplemental report will be submitted.According to the complainant, prior to the procedure, the ligator cap would not attach correctly.There was difficulty experienced upon setting up the device.The procedure was completed with another speedband superview super 7 device.There were no patient complication reported as a result of this event.

• 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: 8336401
• MDR Text Key: 136134428
• Report Number: 3005099803-2019-00571
• 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: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2019
• Device Model Number: M00542253
• Device Catalogue Number: 4225-40
• Device Lot Number: 0022862471
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR