MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number	M0068504001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Obstruction/Occlusion (2422)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated to (b)(6) 2022, date of the revision procedure, as no event/symptom onset date was reported.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: (b)(6).Block h6: the following imdrf patient codes and impact code capture the reportable event of: e2006- mesh erosion.E2328- bladder stones.F19- surgical intervention.
Event or Problem Description
It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during a total vaginal hysterectomy, anterior and posterior colporrhaphy, mid-urethral trans-obturator sling, and cystoscopy procedure on (b)(6) 2011, for the treatment of symptomatic pelvic prolapse and stress urinary incontinence.The patient tolerated the procedure well and was taken to the recovery room in stable condition.On (b)(6) 2022, the patient was admitted and was found to have a bladder stone on cross-sectional imaging.A cystoscopy procedure was performed and revealed bladder stone greater than 2.5 cm adherent to the eroded mesh on the right bladder neck.A 270-micron holmium laser fiber was used to break all the stone and aspirate out all of the fragments.Subsequently, the dome of the bladder was visualized, and a 5mm laparoscopic trocar was placed extra peritoneally above the pubic bone into the bladder under direct visualization.The inner cannula was removed, and a laparoscopic debakey grasper was inserted through the port site into the urinary bladder.The device was exchanged for a 70-degree lens, and the mesh erosion on the bladder wall was examined.The debakey grasper was used to put tension on the mesh and by using the laser, the mesh was excised at the level of the mucosa.The mesh was retracted back underneath the mucosa after it was incised, and the mesh was removed when the other side was cut, completing the excision.Hemostasis of the area around the trocar site as well as the mesh excision site was obtained using a bugbee.This trocar in the suprapubic site was removed and the scope was removed.A 20-french, 2-way foley catheter was placed.The skin site was closed in a subcuticular fashion using a 4-0 monocryl suture and dermabond was applied.The patient was then transferred to the gurney and taken to the pacu in stable condition.The patient was discharged on the same day with a foley catheter.The patient was scheduled for follow-up in approximately 3 weeks for catheter removal.

• Brand Name: OBTRYX SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• 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: 17868412
• Report Number: 3005099803-2023-05164
• Device Sequence Number: 5953820
• Product Code: OTN
• UDI-Device Identifier: 08714729718970
• UDI-Public: 08714729718970
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K040787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• 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): 10/04/2023

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: 01/31/2014
• Device Model Number: M0068504001
• Device Catalogue Number: 850-400
• Device Lot Number: 1ML1010604
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female