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

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

Patient Problems Adhesion(s) (1695); Diarrhea (1811); Inflammation (1932); Pain (1994); Discomfort (2330); Dysuria (2684); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2018, first bsc aware date, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(6).(b)(4).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 device was implanted into the patient during a procedure performed on (b)(6) 2018 for the treatment of stress urinary incontinence and pelvic organ prolapse.After, and as a result of the implantation of the medical device, the patient has suffered serious bodily injuries, including, but not limited to, urinary problems, pain when urinating, vaginal and pelvic pain, and dyspareunia and other injuries similar to the ones described in the fda's public health advisory of (b)(6) 2008 reportedly, the patient has experienced significant mental and physical pain and suffering, and has sustained severe and permanent injury.

Manufacturer Narrative

Additional information: blocks a3, b5, h6: patient codes and h6: impact codes.Correction to blocks e1: initial reporter title and b3 (below).Block b3 date of event: date of event was approximated to november 28, 2018, implant date, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: additional contacts: (b)(6).Attorney for plaintiff.Of counsel: (b)(6).Block h6: patient codes e2330, e1405, e1301, e2401, e2326 and e2101 capture the reportable events of pain, dyspareunia, dysuria, and urinary problems, permanent injury, other injuries, cystitis and adhesions impact code f1901 captures the reportable event of urethrolysis.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.

Event Description

It was reported to boston scientific corporation that an obtryx device was implanted into the patient during a procedure performed on (b)(6), 2018 for the treatment of stress urinary incontinence and pelvic organ prolapse.After, and as a result of the implantation of the medical device, the patient has suffered serious bodily injuries, including, but not limited to, urinary problems, pain when urinating, vaginal and pelvic pain, and dyspareunia and other injuries similar to the ones described in the fda's public health advisory of (b)(6), 2008.Reportedly, the patient has experienced significant mental and physical pain and suffering, and has sustained severe and permanent injury.Additional information received on march 23, 2022: on (b)(6), 2018, the patient presented for a post-operative follow up.The patient was reported to be a little better after her tvt procedure.However, she complained of diarrhea.She was still smoking at that time.Physical examination revealed no abnormalities.She was advised to return or call if the symptoms worsen or persist.Her medical history included colorectal cancer with colorectal resection and status post radiation; radiation cystitis with complicated incontinence.On (b)(6), 2019, the patient had cystoscopy and urethrolysis.During the procedure, it was noted that the anterior vaginal wall was thickened and densely adherent to the urethra.A very little tissue existed between the vaginal mucosa and the urethra.The sling was freed up in the midline and was incised on both sides, completely freeing up the urethra.Preoperative and postoperative diagnoses included history of colorectal cancer with colorectal resection and status post radiation; radiation cystitis with complicated incontinence; and status post tvt sling with ongoing incontinence.

• Brand Name: OBTRYX SYSTEM
• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11662290
• MDR Text Key: 246430497
• Report Number: 3005099803-2021-01496
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2021
• Initial Date FDA Received: 04/13/2021
• Supplement Dates Manufacturer Received: 03/23/2022
• Supplement Dates FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female