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

Model Number M0068505000

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

Patient Problems Adhesion(s) (1695); Stenosis (2263); Injury (2348); Obstruction/Occlusion (2422); Prolapse (2475); No Code Available (3191); Insufficient Information (4580)

Event Date 05/21/2015

Event Type  Injury  

Manufacturer Narrative

This event was reported by the patient's legal representation.The implant surgeon is: dr.(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 system - halo was implanted during an anterior repair obtryx procedure performed on (b)(6) 2012.As reported by the patient's attorney, on (b)(6) 2015, the patient underwent hysteroscopy, dilatation and currettage, and polypectomy procedure.During the procedure, it was observed that the patient had a moderate cystocele, rectocele, stenotic cervix, and multiple fibriods that was slightly thickened.On (b)(6) 2015, the patient had a total abdominal hysterectomy with removal of left ovarian cyst, and adhesiolysis procedure.During the examination under anesthesia of the patient, it was seen that there was no mobility at the uterus at all.Subsequently, adhesions were slowly released.

Event Description

It was reported to boston scientific corporation that an obtryx system - halo was implanted during an anterior repair obtryx procedure performed on (b)(6) 2012.As reported by the patient's attorney, on (b)(6) 2015, the patient underwent hysteroscopy, dilatation and currettage, and polypectomy procedure.During the procedure, it was observed that the patient had a moderate cystocele, rectocele, stenotic cervix, and multiple fibriods that was slightly thickened.On (b)(6) 2015, the patient had a total abdominal hysterectomy with removal of left ovarian cyst, and adhesiolysis procedure.During the examination under anesthesia of the patient, it was seen that there was no mobility at the uterus at all.Subsequently, adhesions were slowly released.

Manufacturer Narrative

Correction to block h6 - the event of obstruction has been replaced with stenosis, non-vascular to better capture the reported event of stenotic cervix, and prolapse was added as one of the patient's symptoms.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Block h6: patient codes e2101, e2337, and e240 to capture the reportable events of adhesion, stenotic cervix, and multiple fibroids respectively.Impact code f19 captures the reportable event of surgery.Conclusion code d17 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.

• Brand Name: OBTRYX 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: 11177301
• MDR Text Key: 227025071
• Report Number: 3005099803-2021-00110
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• Combination Product (y/n): N
• PMA/PMN Number: K040787
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: ML00000822
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR