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

Model Number M0068504000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/30/2022

Event Type  Injury  

Manufacturer Narrative

Report source: medwatch report 0502950000-0200-8007.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx system - curved device was used during a total vaginal hysterectomy, right salpingectomy, anterior & posterior repair transobturator tape vaginal sling placement procedure performed on (b)(6) 2022.During the procedure, the physician was inserting the device on the patient's right side but the blue dilator dislodged in the patient.An attempt to retrieve the detached piece was made but it was not successful.An x-ray as well as a fluoroscopy were taken and showed the detached piece stuck to periosteum, so a decision was made to leave it in place as trying to remove can lead to more harm than help.The procedure to implant the sling was not completed due to this event, and there were no further attempts made to complete the procedure.The patient was transferred to post-anesthesia care unit (pacu).

Event Description

It was reported to boston scientific corporation that an obtryx system - curved device was used during a total vaginal hysterectomy, right salpingectomy, anterior & posterior repair transobturator tape vaginal sling placement procedure performed on (b)(6) 2022.During the procedure, the physician was inserting the device on the patient's right side but the blue dilator dislodged in the patient.An attempt to retrieve the detached piece was made but it was not successful.An x-ray as well as a fluoroscopy were taken and showed the detached piece stuck to periosteum, so a decision was made to leave it in place as trying to remove can lead to more harm than help.The procedure to implant the sling was not completed due to this event, and there were no further attempts made to complete the procedure.The patient was transferred to post-anesthesia care unit (pacu).

Manufacturer Narrative

Block g2: report source: medwatch report (b)(4).Block h6: device code a0501 captures the reportable event of dilator detachment.Block h10: the returned obtryx system curved device was analyzed and found out that the dilators was detached.No other defects were observed to the system.With all the available information, boston scientific concludes that the reported event of dilator detachment was confirmed.It is likely that excessive pulling force and manipulation of the dilator while on the delivery device when trying to place the mesh was applied, resulting in the analyzed device condition and the reported complaint.Furthermore, it was stated, "the procedure to implant the sling was not completed due to this event, and there were no further attempts made to complete the procedure.The patient was transferred to the post-anesthesia care unit (pacu)." information on the condition of the patient was not provided.Therefore, the probable cause selected is: adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on the event.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15214015
• MDR Text Key: 297762436
• Report Number: 3005099803-2022-04527
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718963
• UDI-Public: 08714729718963
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068504000
• Device Catalogue Number: 850-400
• Device Lot Number: 0028231565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 08/11/2022
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• 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): Other
• Patient Age: 46 YR
• Patient Sex: Female