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

Model Number M0068504000

Device Problem Positioning Problem (3009)

Patient Problems Micturition Urgency (1871); Inflammation (1932); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Unspecified Mental, Emotional or Behavioural Problem (4430); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572)

Event Date 01/01/2024

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx system - curved was implanted during a procedure performed on (b)(6) 2020.It was reported that the sling was too tight causing a fold on the urethra.The patient current state included poor emptying of the bladder, residue, urinary tract infections, pyelonephritis, overactive bladder, urges, bladder spasms, electric shocks in the bladder, psychological trauma, loss of confidence, and stress.

Manufacturer Narrative

Block h6: imdrf patient code e1309 captures the reportable event of urinary retention.Imdrf patient code e1310 captures the reportable event of urinary tract infection.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18796787
• MDR Text Key: 336431749
• Report Number: 2124215-2024-10096
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: M0068504000
• Device Catalogue Number: 850-400
• Device Lot Number: 0025391506
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• 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