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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Urinary Retention (2119); Discomfort (2330); No Code Available (3191)
Event Date 10/18/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a solyx sis system was implanted during a stress urinary incontinence sling procedure performed on (b)(6) 2019.According to the complainant, after the procedure, the patient experienced a lot of discomfort and pain.In addition, the patient was unable to pass urine.Reportedly, the sling was removed by the physician on (b)(6) 2019.
 
Manufacturer Narrative
(b)(4).Visual analysis of the returned solyx sis system found significant residue on the device.The carrier was detached on one side of the mesh and there was evidence of tear of the mesh, indicative of excessive force applied.The damge to the appeared to be consistent with removal of the device.No other issues were noted.The dhr review was performed and no anomalies were observed.The review confirmed that the accepted device met all manufacturing specifications and boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.A labeling review was performed and, from the information available, this device was used per directions for use (dfu)/ product label.The dfu indicates "excess tension may cause temporary or permanent lower urinary tract obstruction and retention." therefore, the most probable cause for this complaint is known inherent risk of device.A complaint with a most probable root cause of known inherent risk of device indicates that the reported adverse event is known and documented in the labeling (including both short or long term known complications or adverse reactions).
 
Event Description
It was reported to boston scientific corporation that a solyx sis system was implanted during a stress urinary incontinence sling procedure performed on (b)(6) 2019.According to the complainant, after the procedure, the patient experienced a lot of discomfort and pain.In addition, the patient was unable to pass urine.Reportedly, the sling was removed by the physician on (b)(6) 2019.
 
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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
MDR Report Key9309255
MDR Text Key166931488
Report Number3005099803-2019-05424
Device Sequence Number1
Product Code PAH
UDI-Device Identifier08714729774044
UDI-Public08714729774044
Combination Product (y/n)N
PMA/PMN Number
K081275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/18/2019
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 Expiration Date05/20/2022
Device Model NumberM0068507000
Device Catalogue Number850-700
Device Lot Number0023826539
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2019
Initial Date Manufacturer Received 10/18/2019
Initial Date FDA Received11/12/2019
Supplement Dates Manufacturer Received11/22/2019
Supplement Dates FDA Received12/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
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