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 - MARLBOROUGH SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC
  • 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 - MARLBOROUGH SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC Back to Search Results
Model Number M0068507000
Device Problem Positioning Failure (1158)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2015
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 solyx sis system device was used during an unknown procedure performed on (b)(6) 2015.According to the complainant, during the procedure and inside the patient, the mesh did not release from the shaft tip of the delivery device.The procedure was finished using another solyx sis system device.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
 
Manufacturer Narrative
A visual examination of the returned delivery device of the solyx sis system revealed that the tube of the knob tube assembly is deformed and damaged, confirming the event.The buckling of the tube most likely prevented the carrier from being pushed off of the delivery device, making it impossible to deploy while inside the patient.There is blood and tissue residue on and in the tube of the knob tube assembly.Also, the analysis showed that the mesh is stretched from below the carrier on both sides.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.The investigation concluded that this complaint is associated with a product that meets the design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.The most probable root cause classification is operational context.
 
Event Description
It was reported to boston scientific corporation that solyx sis system device was used during an unknown procedure performed on (b)(6) 2015.According to the complainant, during the procedure and inside the patient, the mesh did not release from the shaft tip of the delivery device.The procedure was finished using another solyx sis system device.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SOLYX SIS SYSTEM
Type of Device
MESH, SURGICAL, SYNTHETIC
Manufacturer (Section D)
BOSTON SCIENTIFIC - MARLBOROUGH
100 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
MEDVENTURE TECHNOLOGY CORPORATION
2301 centennial boulevard
jeffersonville IN 47130
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key5318134
MDR Text Key34138530
Report Number3005099803-2015-03554
Device Sequence Number1
Product Code PAH
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K081275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/25/2015
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 Physician
Device Expiration Date11/30/2017
Device Model NumberM0068507000
Device Catalogue Number850-700
Device Lot NumberML00002736
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/25/2015
Initial Date FDA Received12/22/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/23/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/18/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-