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

Model Number M0068505110

Device Problem Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 05/18/2017

Event Type  Injury  

Manufacturer Narrative

(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 the patient was diagnosed with cystocele and stress urinary incontinence.On (b)(6) 2017, the patient was implanted with an obtryx system - halo during a cystocele repair, transobturator tape urethral sling and cystoscopy procedure.During the procedure, the physician experienced slight difficulty passing the device on the left side.However, he was able to pass the needles on both left and right sides.A cystoscopy was performed and confirmed no injury to the bladder or urethra and the needle pass appeared to be in good order.The procedure was completed with no complications.Cystoscopy confirmed no intravesical foreign bodies or stones, no evidence of mucosal lesions or tumors and no entrance of the mesh into the bladder or urethra.However, as reported by the patient's attorney, the patient has experienced an unspecified injury post procedure.

• 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
• 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: 11419260
• MDR Text Key: 238146821
• Report Number: 3005099803-2021-00867
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2020
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0000053664
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR