Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA Back to Search Results
Model Number M0068507010
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation (2001); Foreign Body In Patient (2687)
Event Date 01/04/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a solyx blue sis system device was used into the patient during a colpocleisis and sling placement procedure performed on (b)(6) 2022 for the treatment of prolapse and stress incontinence.While implanting the device, the physician went through the patient's vaginal epithelial tissue.The physician believes this is due to completing the colpocleisis first and the anatomical changes from the plication.The physician found out that he went through the patient's vaginal epithelial tissue while scoping.Reportedly, the sling was already dislodged from the device so the sling was then removed; the mesh carrier on the first side remained in the patient but the physician was able to remove the remainder of the sling out including the mesh carrier on the other side.The procedure was completed with a new solyx sis system.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h2: additional information blocks b5, d7a and h6: impact codes have been updated based on the additional information received on 08feb2022.Block h6: patient code e2114 captures the reportable event of perforation.Impact code f23 captures the reportable event of suturing the perforation.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a solyx blue sis system device was used into the patient during a colpocleisis and sling placement procedure performed on (b)(6) 2022 for the treatment of prolapse and stress incontinence.While implanting the device, the physician went through the patient's vaginal epithelial tissue.The physician believes this is due to completing the colpocleisis first and the anatomical changes from the plication.The physician found out that he went through the patient's vaginal epithelial tissue while scoping.Reportedly, the sling was already dislodged from the device so the sling was then removed; the mesh carrier on the first side remained in the patient but the physician was able to remove the remainder of the sling out including the mesh carrier on the other side.The procedure was completed with a new solyx sis system.There were no patient complications reported as a result of this event.*additional information received on february 8, 2022: the perforation was repaired by successfully suturing the tear.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SOLYX SIS SYSTEM
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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 Key13419670
MDR Text Key286675789
Report Number3005099803-2022-00253
Device Sequence Number1
Product Code PAH
UDI-Device Identifier08714729961901
UDI-Public08714729961901
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberM0068507010
Device Lot Number0028463552
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/04/2022
Initial Date FDA Received02/01/2022
Supplement Dates Manufacturer Received02/08/2022
Supplement Dates FDA Received03/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age76 YR
Patient SexFemale
-
-