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

Model Number M0068317170

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

Patient Problems Urinary Retention (2119); Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 06/22/2012

Event Type  Injury  

Manufacturer Narrative

(date of event): date of event was approximated to (b)(6) 2012 (implant date) as no event date was reported.This complaint was reported by the patient's lawyer.The device was implanted at (b)(6) by dr.(b)(6).(b)(4).The complainant indicated that the device is not available for return; 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 uphold lite vaginal support system was implanted into the patient on (b)(6) 2012.As reported by the patient's attorney, the patient underwent a revision surgery on (b)(6) 2012 due to obstructive voiding post implant.Boston scientific has been unable to obtain additional information regarding the event to date.

Event Description

It was reported to boston scientific corporation that an uphold lite vaginal support system was implanted into the patient during an anterior uphold mesh, tvt exact and cystoscopy procedure performed on (b)(6) 2012 for the treatment of recurrent prolapse and stress incontinence.As reported by the patient's attorney, the patient underwent a revision surgery on (b)(6) 2012 due to obstructive voiding post implant.

Manufacturer Narrative

Correction to block b5: procedure name and indication of the procedure added.Block b3 (date of event): date of event was approximated to (b)(6) 2012 (implant date) as no event date was reported.Block e1: this complaint was reported by the patient's lawyer.The device was implanted at wangaratta private hospital, wangaratta, vic, australia by dr.(b)(6).Block h6: patient codes 2119, 2422 and 3191 capture the reportable events of urinary retention, obstruction and revision surgery.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device is not available for return; 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.

• Brand Name: PFR KIT UPHOLD LITE VAGINAL SUPPORT SYSTEM
• Type of Device: 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: 11168016
• MDR Text Key: 226777693
• Report Number: 3005099803-2020-06711
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: M0068317170
• Device Catalogue Number: 831-717
• Device Lot Number: ML00000431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 05/12/2022
• Supplement Dates FDA Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female