MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Model Number M0068507010

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

Patient Problems Pain (1994); Deformity/ Disfigurement (2360); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 07/03/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a solyx sis system was used during a transvaginal surgery procedure performed on (b)(6), 2022.As reported by the patient's attorney, the patient suffered significant pain, unnecessary expense, embarrassment, disfigurement, and harm.Due to the pain and complications, the physician fully removed the sling implant on (b)(6), 2023.However, the clamps from the system were left on the patient's bladder, causing continuous pain and suffering.

Manufacturer Narrative

Block b3: the exact event onset date is unknown.The provided event date of (b)(6), 2023, was chosen as a best estimate based on the date when patient had an explant procedure due to significant pain.Blocks d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting and explanting surgeon is dr.(b)(6).(b)(6).Block h6: patient code e2330 captures the reportable event of "significant pain." patient code e2308 captures the reportable event of "disfigurement." patient code e0206 captures the reportable event of "unnecessary expense" and "embarrassment." impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Impact code f1903 captures the reportable event of device explant procedure performed on (b)(6), 2023.

Manufacturer Narrative

D4: model number, d4: lot number, d4: expiration date have been updated based on the additional information received on march 29, 2024.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2023, was chosen as a best estimate based on the date when patient had an explant procedure due to significant pain.Block e1: this event was reported by the patient's legal representation.The implanting and explanting surgeon is (b)(6).Block h6: patient code e2330 captures the reportable event of "significant pain." patient code e2308 captures the reportable event of "disfigurement." patient code e0206 captures the reportable event of "unnecessary expense" and "embarrassment." impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Impact code f1903 captures the reportable event of device explant procedure performed on (b)(6) 2023.

Event Description

It was reported to boston scientific corporation that a solyx sis system was used during a transvaginal surgery procedure performed on (b)(6) 2022.As reported by the patient's attorney, the patient suffered significant pain, unnecessary expense, embarrassment, disfigurement, and harm.Due to the pain and complications, the physician fully removed the sling implant on (b)(6) 2023.However, the clamps from the system were left on the patient's bladder, causing continuous pain and suffering.

• Brand Name: SOLYX SIS SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18517850
• MDR Text Key: 332925970
• Report Number: 2124215-2024-00496
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729961901
• UDI-Public: 08714729961901
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068507010
• Device Catalogue Number: 850701
• Device Lot Number: 0030067101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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): Other; Required Intervention
• Patient Sex: Female