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

Model Number	M0068505000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Retention (2119); Depression (2361); Dysuria (2684); Thrombosis/Thrombus (4440)
Date of Event	08/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an obtryx system - halo was implanted during a procedure performed on (b)(6) 2023, on a patient with a medical history that includes endometriosis, and thrombosis of the ovarian vein.Additionally, the patient had undergone previous unrelated surgeries including three cesarean sections, tubal ligation, and right ovarian cyst laparoscopy.It was reported that after placing the mesh, the patient experienced a painful awakening with right thigh pain, perineal pain, and diffused pain on each side, a fold on the right groin, thigh stabbing sensation, difficulty to sit and stand for long periods, and difficulty in urinating.On (b)(6) 2023, a surgical revision was performed in which the right branch of the sling and the left partial branch of the mesh were removed.During the hospital stay for the procedure, the patient received additional tests which included a blood test and computed tomography (ct) scans of the abdomen and pelvis; both of which had normal results.No signs of hematoma, infection or inflammatory syndrome were identified.Additionally, the patient had a doppler echography of the right inguinal fold which found a small thrombus.; therefore, the patient was given eliquis for medication.The patient noted having several emergency visits and multiple appointments where she underwent magnetic resonance imaging (mri), translabial echography, back mri, angiography scanner, cardio assessment and was on a palliative care for pain.The patient was hospitalized for pain management from (b)(6) 2023.Medical imaging was examined on (b)(6) 2023, noting no abnormality of the hysterectomy site, a partially severed sling with residual left-side arm and a small distal portion of right-side arm present, and important cervico-urethral hypermobility without evidence of obvious sphincter insufficiency.The patient current state included depression, chronic pain, difficulty walking and intimate life reduced to nothing.
Additional Manufacturer Narrative
Block h6: imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e1309 captures the reportable event of urinary retention.Imdrf patient code e1301 captures the reportable event of dysuria.Imdrf impact code f08 captures the reportable event of hospitalization or prolonged hospitalization.Imdrf impact code f1905 captures the reportable event of device revision or replacement.Imdrf impact code f1202 captures the reportable event of disability.
Event or Problem Description
It was reported to boston scientific corporation that an obtryx system - halo was implanted during a procedure performed on (b)(6) 2023, on a patient with a medical history that includes endometriosis, and thrombosis of the ovarian vein.Additionally, the patient had undergone previous unrelated surgeries including three cesarean sections, tubal ligation, and right ovarian cyst laparoscopy.It was reported that after placing the mesh, the patient experienced a painful awakening with right thigh pain, perineal pain, and diffused pain on each side, a fold on the right groin, thigh stabbing sensation, difficulty to sit and stand for long periods, and difficulty in urinating.On (b)(6) 2023, a surgical revision was performed in which the right branch of the sling and the left partial branch of the mesh were removed.During the hospital stay for the procedure, the patient received additional tests which included a blood test and computed tomography (ct) scans of the abdomen and pelvis; both of which had normal results.No signs of hematoma, infection or inflammatory syndrome were identified.Additionally, the patient had a doppler echography of the right inguinal fold which found a small thrombus.; therefore, the patient was given eliquis for medication.The patient noted having several emergency visits and multiple appointments where she underwent magnetic resonance imaging (mri), translabial echography, back mri, angiography scanner, cardio assessment and was on a palliative care for pain.The patient was hospitalized for pain management from (b)(6) 2023, to - (b)(6) 2023.Medical imaging was examined on (b)(6) 2023, noting no abnormality of the hysterectomy site, a partially severed sling with residual left-side arm and a small distal portion of right-side arm present, and important cervico-urethral hypermobility without evidence of obvious sphincter insufficiency.The patient current state included depression, chronic pain, difficulty walking and intimate life reduced to nothing.
Additional Manufacturer Narrative
Block h6: imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e1309 captures the reportable event of urinary retention.Imdrf patient code e1301 captures the reportable event of dysuria.Imdrf impact code f08 captures the reportable event of hospitalization or prolonged hospitalization.Imdrf impact code f1905 captures the reportable event of device revision or replacement.Imdrf impact code f1202 captures the reportable event of disability.

• Brand Name: OBTRYX SYSTEM - HALO
• Common Device Name: 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: 18654640
• Report Number: 2124215-2024-06085
• Device Sequence Number: 20902034
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K040787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2026
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 0031357272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 02/18/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown