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

Model Number M0068505110

Device Problems Defective Device (2588); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Erosion (1750); Pain (1994); Scarring (2061); No Code Available (3191)

Event Date 06/16/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2016, device implantation date, as no event date was reported.(b)(4).This was reported by the patient's lawyer.The device was implanted by dr.(b)(6) at (b)(6) hospital.The surgical intervention was performed by dr.(b)(6).The complaint device is not expected to be returned for evaluation; 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 obtryx ii system - halo was implanted during a trans-obturator tape mid-urethral sling and cystoscopy procedure performed on (b)(6) 2016 to treat stress urinary incontinence.A concomitant procedure for anterior and posterior prolapse repair was also performed by a different physician to treat pelvic organ prolapse.The procedure completed without complications.According to the complainant, after the procedure, the patient experienced vaginal pain, pain during intercourse, muscular groin pain, and leg pain.Subsequently, on (b)(6) 2017, removal of the vaginal sling, removal of vulvar mesh with exploration of the obturator space, urethral lysis, vaginal paravaginal, dissection and mesh removal from the deep obturator internus muscles, removal from the adductor muscles, and anterior colporrhaphy were performed under endotracheal anesthesia.During this surgery, in addition to pain, urethral scarring was also identified.The scar tissue was dissected cephalad, caudad, and laterally.The urethral lysis was performed using sharp dissection to further free the scar tissue.Then, the mesh was fully excised.The entire obtryx ii tot sling was removed.The patient reportedly tolerated the surgery well and was in excellent condition following the surgery.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo was implanted during a trans-obturator tape mid-urethral sling and cystoscopy procedure performed on (b)(6) 2016 to treat stress urinary incontinence.A concomitant procedure for anterior and posterior prolapse repair was also performed by a different physician to treat pelvic organ prolapse.The procedure completed without complications.According to the complainant, after the procedure, the patient experienced vaginal pain, pain during intercourse, muscular groin pain, and leg pain.It was also reported that there was presence of "foreign material" in the patient's vagina.Subsequently, on (b)(6) 2017, removal of the vaginal sling, removal of vulvar mesh with exploration of the obturator space, urethral lysis, vaginal paravaginal, dissection and mesh removal from the deep obturator internus muscles, removal from the adductor muscles, and anterior colporrhaphy were performed under endotracheal anesthesia.During this surgery, in addition to pain, urethral scarring was also identified.The scar tissue was dissected cephalad, caudad, and laterally.The mesh was identified and noted to be at the bladder neck and corded/rolled/banded.It was cut in the midline and freed from the vaginal scar tissue on the left and the right.The urethral lysis was performed using sharp dissection to further free the scar tissue.Then, the mesh was fully excised.The entire obtryx ii tot sling was removed.The patient reportedly tolerated the surgery well and was in excellent condition following the surgery.

Manufacturer Narrative

Block b3: date of event: date of event was approximated to (b)(6) 2016, device implantation date, as no event date was reported.Blocks f10 and h6: patient code 1750 captures the reportable event of "foreign material" in the vagina.Patient code 3191 captures the reportable event of the surgery to address the patient issues.Patient code 1994 captures the reportable event of pain.Patient code 2061 captures the reportable event of urethral scarring.Device code 2588 captures the reportable event of mesh at the bladder neck.Block e1: this was reported by the patient's lawyer.The device was implanted by dr.(b)(6) at (b)(6) hospital.The surgical intervention was performed by dr.(b)(6).Block h6: conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; 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.Block h11: blocks b5, g3 report source, and f10/h6 patient and device codes updated to provide the correct information.

• Brand Name: OBTRYX II SYSTEM - HALO
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8720829
• MDR Text Key: 148756834
• Report Number: 3005099803-2019-03081
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (y/n): N
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2019
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0000029116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR