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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS ADVANCE XP SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
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BOSTON SCIENTIFIC CORPORATION AMS ADVANCE XP SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE Back to Search Results
Model Number 720163-01
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2019
Event Type  malfunction  
Manufacturer Narrative
Estimated event date.
 
Event Description
It was reported the patient had an advance xp sling implant attempted on an unknown date.It was explained that during the attempted implant, the advance sling arm tore.Another advance xp sling was used to achieve the desired results.The patient is in stable condition following this surgery.It was further reported that there were no patient injuries associated with this complaint.
 
Event Description
It was reported the patient had an advance xp sling implant attempted on an unknown date.It was explained that during the attempted implant, the advance sling arm tore.Another advance xp sling was used to achieve the desired results.The patient is in stable condition following this surgery.It was further reported that there were no patient injuries associated with this complaint.
 
Manufacturer Narrative
The advance xp sling arm was reported to have torn during implant.The advance xp sling returned along with both needle passers; the advance xp sling was visually inspected.The sling was not torn nor damaged; however, one end of the sheath was torn at the sheath-sling adhesive bond edge.The other end was cut at the sheath loop, which holds the dilator.Neither dilator was therefore intact on the sheath.One dilator returned and was engaged on the end of the needle passer and the other dilator did not return.The analysis concluded there was not any sling damage; however, the sheath was torn.Based on the event description, the torn sheath is the most probable cause for the reported events.The allegation was therefore confirmed.
 
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Brand Name
AMS ADVANCE XP SLING SYSTEM
Type of Device
MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752 1242
MDR Report Key9379407
MDR Text Key168304193
Report Number2183959-2019-67715
Device Sequence Number1
Product Code OTM
UDI-Device Identifier00878953005560
UDI-Public00878953005560
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 01/10/2020
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 Lay User/Patient
Device Model Number720163-01
Device Catalogue Number720163-01
Device Lot Number0023860807
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2019
Initial Date Manufacturer Received 11/06/2019
Initial Date FDA Received11/26/2019
Supplement Dates Manufacturer Received12/18/2019
Supplement Dates FDA Received01/10/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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