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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
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BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA Back to Search Results
Model Number M0068507000
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a solyx sis system device was used during a sling - solyx sis procedure.During the procedure, "the device did not deploy anchor." the event most likely suggests that the mesh carrier did not release from the shaft tip.The procedure was completed with another of the same device.There were no patient complications reported as a result of the event.
 
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2022, the date bsc was made aware of the event, as no event date was reported.Device code: (b)(4).The device has been received for analysis.Upon 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.
 
Manufacturer Narrative
Block b3 date of event: date of event was approximated to (march 3, 2022, the date bsc was made aware of the event, as no event date was reported.Block h6: device code a150201 captures the reportable event of device unable to deploy mesh carrier.One single incision mesh was returned with the delivery device for analysis.A visual inspection of the returned device identified that one side of the mesh was stretched and had minor blood residue.The mesh had no other sign of deformities as both darts were still attached and intact.The delivery device had no defects and operated as designed.The reported complaint is confirmed due to the stretched mesh.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.Based on the available information, it is likely that procedural factors, such as user handling technique during placement or advancement of the device, resulted in excessive force on the mesh causing it to stretch.It is likely the stretching of the mesh is related to the reported difficulty placing the anchor.The probable cause selected is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on the event.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
 
Event Description
It was reported to boston scientific corporation that a solyx sis system device was used during a sling - solyx sis procedure.During the procedure, "the device did not deploy anchor." the event most likely suggests that the mesh carrier did not release from the shaft tip.The procedure was completed with another of the same device.There were no patient complications reported as a result of the event.
 
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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 Key13964197
MDR Text Key288283903
Report Number3005099803-2022-01624
Device Sequence Number1
Product Code PAH
UDI-Device Identifier08714729774044
UDI-Public08714729774044
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 05/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM0068507000
Device Catalogue Number850-700
Device Lot Number0028548208
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/03/2022
Initial Date FDA Received03/31/2022
Supplement Dates Manufacturer Received04/13/2022
Supplement Dates FDA Received05/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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