MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number	M0068318170
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Hold ps 8/14.It was reported to boston scientific corporation that an uphold lite device was implanted into the patient during robot xi assisted sacrocolpopexy, robot laparoscopic sacrocolpopexy, lysis of adhesions, and cystoscopy procedures performed on june 12, 2020, for the treatment of midline cystocele.During the surgical intervention, the surgeon noted the presence of major bowel and omental adhesions in the central and left regions of the patient's abdomen.Additionally, the surgeon observed that the rectus muscles were not fused in the center and there was a major defect located on the front of the abdomen that was related to the bladder.However, no injury or bleeding was detected during cystoscopy, and both ureteric orifices were properly positioned with clear urine drainage.Moreover, the patient tolerated the procedure well at the end of the procedure the patient was extubated and transferred to the recovery room without any complications.As reported by the patient's attorney, the patient has experienced an unspecified injury.
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2020, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2401 - has been used to capture an unspecified patient injury.The following imdrf impact codes capture the reportable events of: f1903 - has been used in the light of this patient had filed a legal claim for the injuries related to the device.

• Brand Name: UPHOLD LITE
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17541086
• Report Number: 3005099803-2023-04264
• Device Sequence Number: 6534940
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K122459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2019
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000036070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Female