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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 Problems Positioning Failure (1158); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/23/2019
Event Type  malfunction  
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 colpopexy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the mesh carrier failed to deploy.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
 
Manufacturer Narrative
Blocks f10 and h6: device codes 1158 and 2981 capture the reportable events of failure to deploy and shaft tip bent.Block h10: one delivery device was received with a solyx system label.Product analysis found that the tube of the delivery mechanism was ripped toward the distal tip of the device and the shaft tip was bent.There were no issues noted with the handle of the device.Although the mesh was not returned, the damage seen to the device would be expected to interfere with the system releasing the mesh.Based on the returned device, the reported event of failure to deploy is confirmed.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.A labeling review was performed and, from the information available, there is evidence that the user failed to follow the instructions per the directions for use (dfu) / product label.The directions for use say, "warning if excessive resistance is encountered during advancement/ withdrawal, stop and determine remedial action prior to proceeding." based on the condition of the delivery device, it is likely the user encountered resistance and exerted force to advance the device resulting in the torn tube of the delivery mechanism and bent shaft tip.Therefore, the investigation concluded that the most probable cause for this complaint is failure to follow instructions which indicates that problems traced to the user not following the manufacturer's instructions.
 
Event Description
It was reported to boston scientific corporation that a solyx sis system device was used during a colpopexy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the mesh carrier failed to deploy.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
 
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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 Key8710051
MDR Text Key148411842
Report Number3005099803-2019-03075
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 09/04/2019
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 Expiration Date06/06/2021
Device Model NumberM0068507000
Device Catalogue Number850-700
Device Lot Number0022222059
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2019
Initial Date Manufacturer Received 05/23/2019
Initial Date FDA Received06/18/2019
Supplement Dates Manufacturer Received08/09/2019
Supplement Dates FDA Received09/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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