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

Model Number 850-400

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

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Depression (2361); Constipation (3274); Dyspareunia (4505); Insufficient Information (4580)

Event Date 10/12/2010

Event Type  Injury  

Manufacturer Narrative

(b)(6) the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.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 obtryx was implanted on (b)(6) 2008.On (b)(6) 2010, the patient underwent further surgery for the implantation of a second obtryx sling.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; perineum pain; anal pain; thigh pain; painful intercourse; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; damage; psychiatric injury.Surgical interventions: on (b)(6) 2010 the patient underwent further surgery regarding the obtryx implant(s) for the following purpose: implant of cook product.On (b)(6) 2020 the patient underwent further surgery regarding the obtryx implant for the following purpose: vaginal rectopexy/suspension procedure.Nonsurgical treatments: the patient was treated with pain medication: panadol osteo for the treatment of: pain.Treatment duration: everyday.The patient was treated with psychological medication: cymbalta for the treatment of: nerve pain and depression.The patient was treated with other medication (please specify): mobic, prednisone.Device 2 of 2.

Manufacturer Narrative

Block a1: (b)(6).Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.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.Correction: a previous report for this patient and device has been sent under mfr report # 3005099803-2021-00014.

Event Description

It was reported to boston scientific corporation that an obtryx was implanted on (b)(6) 2008.On (b)(6) 2010, the patient underwent further surgery for the implantation of a second obtryx sling.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; perineum pain; anal pain; thigh pain; painful intercourse; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; recurrent incontinence; aggravated incontinence; damage; psychiatric injury.Surgical interventions: on (b)(6) 2010 the patient underwent further surgery regarding the obtryx implant(s) for the following purpose: implant of cook product.On (b)(6) 2020 the patient underwent further surgery regarding the obtryx implant for the following purpose: vaginal rectopexy/suspension procedure.Nonsurgical treatments: the patient was treated with pain medication: panadol osteo for the treatment of: pain.Treatment duration: everyday.The patient was treated with psychological medication: cymbalta for the treatment of: nerve pain and depression.The patient was treated with other medication (please specify): mobic, prednisone.Device 2 of 2.

• Brand Name: OBTRYX SYSTEM - CURVED
• 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: 12930121
• MDR Text Key: 286446997
• Report Number: 3005099803-2021-07377
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K040787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 850-400
• Device Catalogue Number: 850-400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 89 KG