MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS ADVANCE XP SLING SYSTEM; SURGICAL MESH

Catalog Number 720163-02

Device Problem Torn Material (3024)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Date 12/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during the insertion of advance xp mesh, the plastic sleeve ripped and came free from the mesh leaving the exposed mesh incompletely placed within the patient.A piece of plastic remained in the patient's pelvis and had to be found and removed.An additional incision had to be made in the patient's groin to find the plastic for removal.The mesh had to be manually pulled and placed into position without the introducer needle.The ripped plastic sleeve was discarded and the mesh arm was physically dragged into position.The mesh was eventually well placed into position, and after cystoscopy, it was determined that a good placement of mesh had been achieved and the urethral coaptation was good.No further patient complications were reported in relation to this event.

• Brand Name: AMS ADVANCE XP SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 7157944
• MDR Text Key: 96179054
• Report Number: 2183959-2018-00001
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

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 Expiration Date: 03/19/2018
• Device Catalogue Number: 720163-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 01/02/2018
• Supplement Dates Manufacturer Received: 12/06/2017
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR