MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH UPSYLON¿; MESH, SURGICAL, SYNTHETIC

Model Number M0068318200

Device Problem Torn Material (3024)

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

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.However, the complainant reported that the device was not expired.The complainant indicated that the device is implanted and will not 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 an upsylon¿ was implanted during a laproscopic sacrocolpopexy procedure performed on (b)(6) 2016.According to the complainant, after the procedure, the patient's prolapse returned.On mri, it showed that the mesh tore where the anterior, posterior, and sacral piece connect.There were no patient complications reported as a result of this event.The patient's condition was reported to be fine.

Event Description

It was reported to boston scientific corporation that an upsylon¿ was implanted during a laproscopic sacrocolpopexy procedure performed on (b)(6) 2016.According to the complainant, after the procedure, the patient's prolapse returned.On mri, it showed that the mesh tore where the anterior, posterior, and sacral piece connect.There were no patient complications reported as a result of this event.The patient's condition was reported to be fine.Additional information received on april 26, 2017.The patient was brought back for surgery on the (b)(6) 2017.The physician discovered that the mesh did not tear but the sacral portion of the y-mesh had stretched.The physician then used a piece of polyform mesh and sutured it to the upsylon mesh to create a bridge.

• Brand Name: UPSYLON¿
• Type of Device: MESH, SURGICAL, SYNTHETIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6514889
• MDR Text Key: 73454307
• Report Number: 3005099803-2017-01281
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068318200
• Device Catalogue Number: 831-820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2017
• 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 Number: 1
• Patient Outcome(s): Required Intervention