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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 M0068507010
Device Problems Difficult to Advance (2920); Material Deformation (2976)
Patient Problem Perforation (2001)
Event Date 10/16/2020
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 device was used during a solyx sling procedure performed on (b)(6) 2020.According to the complainant, during the procedure, there was a difficulty passing the device through the tissue and the sling went more into the bladder.The mesh also became stretched with trying to adjust as it did not fit as intended.The procedure was completed with another solyx sis system device.The condition of the patient after the procedure was reportedly good.
 
Event Description
It was reported to boston scientific corporation that a solyx sis system device was used during a solyx sling procedure performed on (b)(6) 2020.According to the complainant, during the procedure, there was a difficulty passing the device through the tissue and the sling went more into the bladder.The mesh also became stretched with trying to adjust as it did not fit as intended.The procedure was completed with another solyx sis system device.The condition of the patient after the procedure was reportedly good.
 
Manufacturer Narrative
Block h6: patient code 2001 captures the reportable event of bladder perforation.Block h10: one single incision mesh was returned.A visual examination of the returned mesh revealed that it was stretched on both sides.Both mesh carriers were present and contained procedural residue.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 reported information, the user experienced difficulty passing the device through the tissue.This was observed from the stretched mesh during product return analysis.Therefore, the investigation concluded that the most probable cause for this complaint 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.The adverse event of bladder perforation is accounted for in the risk documentation and labeling, and is an anticipated adverse outcome associated with normal use of the device.The perforation is a known inherent risk of the device.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
 
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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 Key10825538
MDR Text Key215921723
Report Number3005099803-2020-05176
Device Sequence Number1
Product Code PAH
UDI-Device Identifier08714729961901
UDI-Public08714729961901
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,health
Type of Report Initial,Followup
Report Date 01/13/2021
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 Date09/08/2023
Device Model NumberM0068507010
Device Lot Number0025980606
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2020
Initial Date Manufacturer Received 10/19/2020
Initial Date FDA Received11/11/2020
Supplement Dates Manufacturer Received12/16/2020
Supplement Dates FDA Received01/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age79 YR
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