ADVANTAGE FIT SYSTEM
Report
- Report Number
- 3005099803-2022-04927
- Event Type
- Injury
- Date Received
- August 30, 2022
- Date of Event
- October 10, 2017
- Report Date
- September 21, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OTN
- UDI-DI
- 08714729772880
- PMA / PMN Number
- K020110
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
DATE OF EVENT WAS APPROXIMATED TO (B)(6), 2017, IMPLANT PROCEDURE DATE, AS NO EVENT DATE WAS REPORTED. THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANT SURGEON IS: (B)(6). (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, A DEVICE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
BLOCK H2: CORRECTION BLOCK B5 NARRATIVE HAS BEEN CORRECTED. BLOCK B3 DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2017, IMPLANT PROCEDURE DATE, AS NO EVENT DATE WAS REPORTED. BLOCK E1: THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANT SURGEON IS: (B)(6). WOMEN'S CENTER FOR ADVANCED SURGERY 1948 OLD OCILLA ROAD, TIFTON, GA UNITED STATES 31794 BLOCK H6: PATIENT CODE E1405, E2330, E2006 CAPTURE THE REPORTABLE EVENTS OF DYSPAREUNIA, PAIN AND EROSION. IMPACT CODE F1903 CAPTURES THE REPORTABLE EVENT OF MESH REMOVAL. CONCLUSION CODE D17 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 DEVICE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TRANSVAGINAL TAPE PROCEDURE AND CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6), 2017, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE AND HYPERMOBILE URETHRA. REPORTEDLY, THERE WE NO PATIENT COMPLICATIONS DURING THE PROCEDURE AND SHE WAS TAKEN TO THE RECOVERY ROOM IN A STABLE CONDITION. AFTER THE MESH IMPLANTATION, THE PATIENT UNDERWENT A REMOVAL OF PREVIOUS MID URETHRAL SLING SECONDARY TO MESH EXPOSURE AND PLACEMENT OF NEW MID URETHRAL SLING WITH CYSTOSCOPY ON (B)(6), 2019. PRIOR TO INSERTING THE ALLIS CLAMPS, THE EXPOSED VAGINAL MESH WAS PALPATED AND FOUND. TWO ALLIS CLAMPS WERE PUT 1.5 CM BELOW THE EXTERNAL URETHRAL MEATUS AT THIS TIME, AND THE EXPOSED VAGINAL MESH AND TIGHT VAGINAL MESH IN THE LEFT VAGINAL SULCUS AREA WERE REMOVED. FROM THE EXTERNAL URETHRAL MEATUS, A TOTAL OF 2 CM OF GRAFT WAS REMOVED. THE PATIENT WAS THEN TURNED TO THE PERIURETHRAL AREA AND THE NEW MID-URETHRAL SLING WAS PUT. METZENBAUM SCISSORS WERE USED TO DO A DISSECTION INTO THE PERIURETHRAL AREA AND TO THE SUPERIOR BORDER OF THE INFERIOR RAMUS. THERE WAS GOOD HEMOSTASIS. THE MID URETHRA WAS ALSO SEPARATED FROM THE VAGINAL TISSUE IN THE MIDLINE TO ENSURE PROPER SLING COAPTATION. IN ADDITION, AN ALTIS TROCAR WAS INSERTED INTO THE PERIURETHRAL REGION TO THE LEFT OF THE INFERIOR RAMUS. TWO POPS WERE PALPATED THROUGH THE MEMBRANE AND FASCIA OF THE LEFT OBTURATOR INTERNUS, AND HENCE INTO THE MUSCLE. THE SAME SURGERY WAS PERFORMED BILATERALLY ON THE RIGHT SIDE. AGAIN, GOOD HEMOSTASIS WAS OBSERVED. THE TENSION OF THE SLING WAS ADJUSTED USING A RIGHT-ANGLE CLAMP. A CYSTOSCOPY WAS CARRIED OUT. THERE WERE NO EVIDENCE OF TRAUMA OR INJURIES, AND BOTH URETERAL ORIFICES WERE PATENT. INDIGO CARMINE SOLUTION AND BLUE DYE WERE EFFLUXED BILATERALLY FROM BOTH URETERAL ORIFICES. CYSTOSCOPY WAS USED TO INSERT APPROXIMATELY 300 ML OF NORMAL SALINE INTO THE BLADDER. THE FOCUS WAS SHIFTED TO THE MID-URETHRAL SLING. FOR ADEQUATE TENSIONING, A RIGHT-ANGLE CLAMP WAS PUT UNDER THE MID URETER ONCE MORE. THE MID URETHRAL INCISION WAS CLOSED WITH A 2.0 VICRYL ON A UR 6 NEEDLE. TO AVOID BLOOD DRAIN, THIS WAS DONE IN AN INTERMITTENT METHOD. THE PATIENT WAS BROUGHT TO THE POST-ANESTHESIA CARE UNIT AFTER BEING AWAKENED. SHE WILL BE SENT HOME WITH INSTRUCTIONS AND MEDICATION AFTER UNDERGOING A BLADDER DRILL IN THE RECOVERY ROOM. SHE WILL RETURN TO THE OFFICE IN TWO WEEKS FOR A POSTOPERATIVE EXAM.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TRANSVAGINAL TAPE PROCEDURE AND CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2017, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE AND HYPERMOBILE URETHRA. REPORTEDLY, THERE WE NO PATIENT COMPLICATIONS DURING THE PROCEDURE AND SHE WAS TAKEN TO THE RECOVERY ROOM IN A STABLE CONDITION. AFTER THE MESH IMPLANTATION, THE PATIENT DEVELOPED PELVIC PAIN, DYSPAREUNIA, AND MESH EXPOSURE. THE PATIENT UNDERWENT A REMOVAL OF PREVIOUS MID URETHRAL SLING SECONDARY TO MESH EXPOSURE AND PLACEMENT OF NEW MID URETHRAL SLING WITH CYSTOSCOPY ON (B)(6) 2019. PRIOR TO INSERTING THE ALLIS CLAMPS, THE EXPOSED VAGINAL MESH WAS PALPATED AND FOUND. TWO ALLIS CLAMPS WERE PUT 1.5 CM BELOW THE EXTERNAL URETHRAL MEATUS AT THIS TIME, AND THE EXPOSED VAGINAL MESH AND TIGHT VAGINAL MESH IN THE LEFT VAGINAL SULCUS AREA WERE REMOVED. FROM THE EXTERNAL URETHRAL MEATUS, A TOTAL OF 2 CM OF GRAFT WAS REMOVED. THE PATIENT WAS THEN TURNED TO THE PERIURETHRAL AREA AND THE NEW MID-URETHRAL SLING WAS PUT. METZENBAUM SCISSORS WERE USED TO DO A DISSECTION INTO THE PERIURETHRAL AREA AND TO THE SUPERIOR BORDER OF THE INFERIOR RAMUS. THERE WAS GOOD HEMOSTASIS. THE MID URETHRA WAS ALSO SEPARATED FROM THE VAGINAL TISSUE IN THE MIDLINE TO ENSURE PROPER SLING COAPTATION. IN ADDITION, AN ALTIS TROCAR WAS INSERTED INTO THE PERIURETHRAL REGION TO THE LEFT OF THE INFERIOR RAMUS. TWO POPS WERE PALPATED THROUGH THE MEMBRANE AND FASCIA OF THE LEFT OBTURATOR INTERNUS, AND HENCE INTO THE MUSCLE. THE SAME SURGERY WAS PERFORMED BILATERALLY ON THE RIGHT SIDE. AGAIN, GOOD HEMOSTASIS WAS OBSERVED. THE TENSION OF THE SLING WAS ADJUSTED USING A RIGHT-ANGLE CLAMP. A CYSTOSCOPY WAS CARRIED OUT. THERE WERE NO EVIDENCE OF TRAUMA OR INJURIES, AND BOTH URETERAL ORIFICES WERE PATENT. INDIGO CARMINE SOLUTION AND BLUE DYE WERE EFFLUXED BILATERALLY FROM BOTH URETERAL ORIFICES. CYSTOSCOPY WAS USED TO INSERT APPROXIMATELY 300 ML OF NORMAL SALINE INTO THE BLADDER. THE FOCUS WAS SHIFTED TO THE MID-URETHRAL SLING. FOR ADEQUATE TENSIONING, A RIGHT-ANGLE CLAMP WAS PUT UNDER THE MID URETER ONCE MORE. THE MID URETHRAL INCISION WAS CLOSED WITH A 2.0 VICRYL ON A UR 6 NEEDLE. TO AVOID BLOOD DRAIN, THIS WAS DONE IN AN INTERMITTENT METHOD. THE PATIENT WAS BROUGHT TO THE POST-ANESTHESIA CARE UNIT AFTER BEING AWAKENED. SHE WILL BE SENT HOME WITH INSTRUCTIONS AND MEDICATION AFTER UNDERGOING A BLADDER DRILL IN THE RECOVERY ROOM. SHE WILL RETURN TO THE OFFICE IN TWO WEEKS FOR A POSTOPERATIVE EXAM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299951 | ADVANTAGE FIT SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR | OTN | BOSTON SCIENTIFIC CORPORATION | M0068502110 | 0021006040 | 08714729772880 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Female | Required Intervention |