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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2023

Event Type  Death  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Block h6: imdrf impact code f02 captures the reportable event of patient death.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo was implanted into the patient during a midurethal sling procedure performed on an unknown date for the treatment of stress urinary incontinence.It was reported that the patient passed away within seventy-two hours post-implantation due to an unknown reason.No further information has been able to be obtained despite good faith efforts.

Manufacturer Narrative

Block h11: correction to block h6.Patient code f24 has been added for the unspecified outcome/event that led to death.Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Block h6: imdrf impact code f02 captures the reportable event of patient death.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo was implanted into the patient during a midurethal sling procedure performed on an unknown date.It was reported that the patient passed away within seventy-two hours post-implantation due to an unknown reason.No further information has been able to be obtained despite good faith efforts.

• 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18440115
• MDR Text Key: 331858258
• Report Number: 2124215-2023-74064
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

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
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0031248932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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): Death