MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON; MESH, SURGICAL, SYNTHETIC

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 06/19/2018

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 voluntary user medwatch number is mw5086450.The 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

This manufacturer report pertains to the first of two devices implanted during two different procedures.It was reported to boston scientific corporation that two upsylon devices were implanted for a partial hysterectomy and to correct uterine prolapse.According to the complainant, the first device was implanted on (b)(6) 2018.Reportedly, the patient had to undergo another procedure for mesh repair and revision due to the mesh collapsing and a second upsylon mesh was then implanted on (b)(6) 2018.However, she again had to undergo another surgery on (b)(6) 2019 to remove the broken mesh and to repair the blockage in her bladder due to the mesh.

• Brand Name: UPSYLON
• Type of Device: MESH, SURGICAL, SYNTHETIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL; coilleach; spiddal, co galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8689756
• MDR Text Key: 147704136
• Report Number: 3005099803-2019-02897
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention