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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER OBTRYX II SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

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BOSTON SCIENTIFIC - SPENCER OBTRYX II SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Model Number M0068505110
Device Problem Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2018
Event Type  malfunction  
Manufacturer Narrative
A visual examination of the returned device revealed that the that the leader loops are not cut on either sleeve.The mesh is stretched and broken which allowed it to unravel to where the leader loop is attached to the mesh within the sleeve.As a result, the mesh detached from the sleeve and leader loop prematurely, without cutting the leader.The delivery device revealed no damage.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 an obtryx ii system was used during an insertion of transobturator sling procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the sleeve detached from the mesh prior to cutting the suture (leader loop).The tape was then removed and the procedure was completed with another obtryx ii system.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.This event has been deemed reportable based on the investigation results: mesh torn.
 
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Brand Name
OBTRYX II SYSTEM
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
Manufacturer (Section D)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer (Section G)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key7638998
MDR Text Key112377513
Report Number3005099803-2018-01942
Device Sequence Number1
Product Code OTN
UDI-Device Identifier08714729837565
UDI-Public08714729837565
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K121754
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 06/04/2018
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 Date09/04/2020
Device Model NumberM0068505110
Device Catalogue Number850-511
Device Lot Number21093241
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/04/2018
Initial Date FDA Received06/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2017
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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