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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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BOSTON SCIENTIFIC - MARLBOROUGH ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Model Number M0068502000
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/03/2014
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an advantage system was used during a procedure performed on (b)(6) 2014.According to the complainant, during preparation and outside the patient, a hair was noted inside the sterile packaging.It was reported that no damage was noted on the package.The procedure was completed with another advantage single handle kit.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 stable.
 
Manufacturer Narrative
Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that an advantage system was used during a procedure performed on (b)(6) 2014.According to the complainant, during preparation and outside the patient, a hair was noted inside the sterile packaging.It was reported that no damage was noted on the package.The procedure was completed with another advantage single handle kit.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 stable.
 
Manufacturer Narrative
Analysis of the returned advantage system device found an open package with the alleged contaminant taped to the underside of the tyvek lid most likely by the customer.The contaminant appears to be a piece of thread that measures 6.5 mm long.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.Review and analysis of all available information fails to indicate a root cause or probable root cause.Therefore, the root cause of this complaint is undeterminable.
 
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Brand Name
ADVANTAGE 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 (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 Key4216898
MDR Text Key4970786
Report Number3005099803-2014-03472
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K020110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/03/2014
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 Date06/30/2017
Device Model NumberM0068502000
Device Catalogue Number850-200
Device Lot NumberML00002459
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/22/2014
Initial Date FDA Received10/31/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/20/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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