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 Neuropathy (1983); Pain (1994)

Event Date 06/22/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf patient codes e2330 capture the reportable event of pain.Imdrf patient codes e0126 capture the reportable event of neuropathy.Imrdf impact code f2303 captures the reportable event of treatment with analgesics.Imrdf impact code f1905 captures the reportable event of device revision or replacement.

Event Description

It was reported to boston scientific corporation that an obtryx system halo device was implanted during a suburethral sling procedure performed on (b)(6) 2021.It was reported that after the placement of the sling, the patient experienced neuropathic-type pain at the anal, perineal, inner thigh, and outer hip levels.The patient was treated with analgesics.On (b)(6) 2023, a 7-centimeter portion of the sling was removed given the ineffectiveness of analgesic drug treatment.

Event Description

It was reported to boston scientific corporation that an obtryx system halo device was implanted during a suburethral sling procedure performed on (b)(6) 2021.It was reported that after the placement of the sling, the patient experienced neuropathic-type pain at the anal, perineal, inner thigh, and outer hip levels.The patient was treated with analgesics.On (b)(6) 2023, a 7-centimeter portion of the sling was removed given the ineffectiveness of analgesic drug treatment.

Manufacturer Narrative

Blocks d7a and h10 (block e1 note below) have updated based on the additional information received on august 2, 2023.Block e1: this event was reported by ch pitie salpetriere aphp where the partial removal of the mesh was performed.Block h6: imdrf patient codes e2330 capture the reportable event of pain.Imdrf patient codes e0126 capture the reportable event of neuropathy.Imrdf impact code f2303 captures the reportable event of treatment with analgesics.Imrdf impact code f1905 captures the reportable event of device revision or replacement.

Event Description

It was reported to boston scientific corporation that an obtryx system halo device was implanted during a suburethral sling procedure performed on (b)(6) 2021.It was reported that after the placement of the sling, the patient experienced neuropathic-type pain at the anal, perineal, inner thigh, and outer hip levels.The patient was treated with analgesics.On (b)(6) 2023, a 7-centimeter portion of the sling was removed given the ineffectiveness of analgesic drug treatment.

Manufacturer Narrative

Block h11: correction to block b5 - obtryx implantation date was corrected.Block e1: this event was reported by ch pitie salpetriere aphp where the partial removal of the mesh was performed.Block h6: imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e0126 captures the reportable event of neuropathy.Imrdf impact code f2303 captures the reportable event of treatment with analgesics.Imrdf impact code f1905 captures the reportable event of mesh revision.Block h10: upon receipt at our quality assurance laboratory, this obtryx system - halo underwent a thorough analysis.The device was visually inspected, and it revealed signs of normal usage, stretching and a part was missing.Since it was reported that the mesh was removed from the patient, the damage likely occurred during removal and should not be considered a failure.The product labeling review identified that the device was used per the directions for use (dfu) and that the adverse event of pain is a potential outcome of this procedure.The reported patient observations of neuropathy, medications and device revision are secondary effects of the other reported events or are unrelated to the device i.E., associated with patient factors, concomitant medical issues, concomitant medications, etc.Based on the information available and analysis results, the reported patient symptoms are known risks associated with obtryx system procedures and are noted as such in the device instructions for use.A conclusion code of known inherent risk of device was assigned to this investigation.

• 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
• 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 ; 5086834015
• MDR Report Key: 17374091
• MDR Text Key: 319602983
• Report Number: 3005099803-2023-03927
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K040787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 0026111361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• 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