MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS ADVANCE XP SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE

Model Number 720163-01

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2019

Event Type  malfunction  

Event Description

It was reported by the physician that the advance xp male sling box seal was broken.The device was not used on a patient.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.

Event Description

It was reported by the physician that the advance xp male sling box seal was broken.The device was not used on a patient.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.

Manufacturer Narrative

The box was returned for visual inspection.The sticker to seal the box shut was easily removable.Dust was noted on the sticky parts of the sticker.Sticker seal issues would not lead to sterilization issues.Review of manufacturing documentation was not performed as the complaint is associated with an ncep.An overall conclusion code of "cause not established" was selected as the investigation findings do not lead to a clear conclusion about the cause of the reported event.Ncep 100957 has been issued by the distribution center in quincy to identify the probable cause of this event.

• 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 Key: 8392108
• MDR Text Key: 137878442
• Report Number: 2183959-2019-61335
• Device Sequence Number: 1
• Product Code: OTM
• UDI-Device Identifier: 00878953005560
• UDI-Public: 00878953005560
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

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: Lay User/Patient
• Device Expiration Date: 09/24/2019
• Device Model Number: 720163-01
• Device Catalogue Number: 720163-01
• Device Lot Number: 0023159002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 04/25/2019
• Supplement Dates FDA Received: 05/20/2019
• Patient Sequence Number: 1