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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MARLBOROUGH 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 Consequences Or Impact To Patient (2199)
Event Date 06/27/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complainant indicated that the device is disposed and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that an obtryx ii system was used during an unknown procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the physician inserted the sling but when he went to change the tensioning, the sling broke.The procedure was completed with another obtryx ii system.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 fine.
 
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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 - MARLBOROUGH
100 boston scientific way
marlborough MA 01752
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key6727045
MDR Text Key80504956
Report Number3005099803-2017-02065
Device Sequence Number1
Product Code OTN
UDI-Device Identifier08714729837565
UDI-Public(01)08714729837565(17)20191129(10)0000049917
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121754
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 06/28/2017
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 Date11/29/2019
Device Model NumberM0068505110
Device Catalogue Number850-511
Device Lot Number0000049917
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/28/2017
Initial Date FDA Received07/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2016
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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