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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Model Number M0068502110
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/09/2019
Event Type  malfunction  
Manufacturer Narrative
The exact age of the patient is unknown, however, it was reported the patient was over 18 years.The event date was approximated to (b)(6) 2019, the date the complaint was first reported to bsc, as no event date was reported.(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 an advantage fit system was about to be used during a mid-urethral sling placement procedure performed on an unknown date.According to the complainant, during preparation, it was noticed that part of the inner packaging and the sling itself were caught in the seal of the outside packaging.Reportedly, the device was not used in the patient.The procedure was completed with another advantage fit system.There were no patient complications as a result of the event.The patient's condition at the conclusion of the procedure was reported to be good.
 
Manufacturer Narrative
The exact age of the patient is unknown, however, it was reported the patient was over 18 years.The event date was approximated to october 9, 2019, the date the complaint was first reported to bsc, as no event date was reported.Device code of 1444 captures the reportable event of the "part of the inner wrapping and the sling were sealed into the packaging." an advantage fit system was received open in the packaging.Visual analysis found no issues with the device.The mesh and delivery device were inspected for damage possibly caused by sticking to the pack no issues were found.The packaging was inspected for any residue or defects that could have made unpacking the device difficult, and no issues or residue were noted.The reported complaint is not confirmed.The dhr review was performed and no anomalies were observed, the review confirmed that the accepted device met all manufacturing specifications and boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.After analysis, it was determined that the device did not present any visual issue and it worked as intended.It did not show evidence of either the alleged issue or any defect that could have contributed to the event reported.Therefore, the investigation concluded that the most probable cause for the reported issue is no problem detected, since the device complaint or problem cannot be confirmed.
 
Event Description
It was reported to boston scientific corporation that an advantage fit system was about to be used during a mid-urethral sling placement procedure performed on an unknown date.According to the complainant, during preparation, it was noticed that part of the inner packaging and the sling itself were caught in the seal of the outside packaging.Reportedly, the device was not used in the patient.The procedure was completed with another advantage fit system.There were no patient complications as a result of the event.The patient's condition at the conclusion of the procedure was reported to be good.
 
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Brand Name
ADVANTAGE FIT SYSTEM
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9278430
MDR Text Key182381044
Report Number3005099803-2019-05310
Device Sequence Number1
Product Code OTN
UDI-Device Identifier08714729772880
UDI-Public08714729772880
Combination Product (y/n)N
PMA/PMN Number
K020110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/26/2019
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 Date05/06/2022
Device Model NumberM0068502110
Device Catalogue Number850-211
Device Lot Number0023753518
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2019
Initial Date Manufacturer Received 10/09/2019
Initial Date FDA Received11/05/2019
Supplement Dates Manufacturer Received11/05/2019
Supplement Dates FDA Received11/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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