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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 06/13/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2017 was chosen as a best estimate based on the date of the mesh was implanted.The complainant was unable to report the upn and lot number; therefore, the unique identifier (udi) #, manufacture date, and expiration date are unknown.Initial reporter name and address: this event was reported to boston scientific corporation legal by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that an upsylon y-mesh was implanted during a robotic assisted laparoscopic lysis of adhesions, sacral colpopexy with upsylon mesh, cystourethroscopy and excision of right-side wall nodules procedures performed on (b)(6) 2017 for the preoperative diagnoses of vaginal vault prolapse and cystocele.Intra-operative findings included adhesions from the omentum to the pelvis and into the left lower pelvis.There was a side wall lesion on the right that to be remnant ovary.Cystourethroscopy revealed brisk bilateral urethral orifice reflux with no foreign body.Urethra was normal in appearance.She was taken to post-anesthesia care unit (pacu) in stable condition.As reported by the patient's attorney, the patient has experienced an unspecified injury.

• 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: 16103631
• MDR Text Key: 306717881
• Report Number: 3005099803-2022-07687
• Device Sequence Number: 1
• Product Code: KOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2022
• 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): Other
• Patient Age: 53 YR
• Patient Sex: Female