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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT ULTRA SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET
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BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT ULTRA SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET Back to Search Results
Model Number M0068502160
Device Problems Difficult to Remove (1528); Positioning Problem (3009)
Patient Problem Urinary Retention (2119)
Event Date 11/18/2021
Event Type  Injury  
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complaint device is not expected to 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 on november 18, 2021, an advantage fit ultra system device was used during a bladder sling placement the physician had difficulty removing the sleeves of the advantage fit ultra device during the procedure which resulted in the mesh being over tensioned.Immediately following the procedure, the patient began experiencing urinary retention.In the physician's assessment, the over tensioning of the mesh could have contributed to the patient's symptoms.The patient was catheterized for four weeks until the symptoms resolved.The patient will be monitored and is expected to make a full recovery.
 
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complaint device is not expected to 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 on (b)(6) 2021, an advantage fit ultra system device was used during a bladder sling placement the physician had difficulty removing the sleeves of the advantage fit ultra device during the procedure which resulted in the mesh being over tensioned.Immediately following the procedure, the patient began experiencing urinary retention.In the physician's assessment, the over tensioning of the mesh could have contributed to the patient's symptoms.The patient was catheterized for four weeks until the symptoms resolved.The patient will be monitored and is expected to make a full recovery.
 
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Brand Name
ADVANTAGE FIT ULTRA SYSTEM
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key13254292
MDR Text Key286016541
Report Number3005099803-2021-08172
Device Sequence Number1
Product Code OTN
UDI-Device Identifier00191506007669
UDI-Public00191506007669
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K211223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM0068502160
Device Catalogue Number850216
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/15/2021
Initial Date FDA Received01/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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