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

Model Number M00542250

Device Problems Component Missing (2306); Defective Device (2588); Failure to Fire (2610)

Patient Problems Laceration(s) (1946); Tissue Damage (2104)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device is not available for return.If any further relevant information is received, 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 a procedure performed on (b)(6) 2019.According to the complainant, the last band on the ligator head was missing.Additionally, the white band on the ligator head was reportedly frayed.During attempted deployment, there was a problem with release regarding a metallic element in the ligator head, having caused lesions of the mucous membranes.This lead to failure to implant failure.Intervention was performed on the same day by the treating physician.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: problem code 2610 has been selected to address the reportable failure mode of bands failed to deploy.Problem code 2588 has been selected to address the reportable failure mode of bands frayed.Patient code 2104 has been selected to address the reportable event of tissue damage requiring intervention.Block h10: according to the complainant, the suspect device is not available for return.If any further relevant information is received, 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 a procedure performed on (b)(6) 2019.According to the complainant, the last band on the ligator head was missing.Additionally, the white band on the ligator head was reportedly frayed.During attempted deployment, there was a problem with release regarding a metallic element in the ligator head, having caused lesions of the mucous membranes.This lead to failure to implant failure.Intervention was performed on the same day by the treating physician.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.

• 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: 8776084
• MDR Text Key: 150560823
• Report Number: 3005099803-2019-03448
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 08714729201953
• UDI-Public: 08714729201953
• 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: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2020
• Device Model Number: M00542250
• Device Catalogue Number: 4225
• Device Lot Number: 0023716373
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention