MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068318170

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/27/2018

Event Type  Injury  

Manufacturer Narrative

The exact age of the patient is unknown, however, it was reported the patient was over 18 years.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure 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 uphold lite with capio slim device was used during a pelvic floor repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the dart detached from the suture during the deployment and it remained inside the patient.Reportedly, the suture was not tensioned during deployment of the suture.The procedure was completed with another uphold lite with capio slim.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be stable.Should additional relevant details become available; a supplemental report will be submitted.

Manufacturer Narrative

Age or date of birth: the exact age of the patient is unknown, however, it was reported the patient was over 18 years.Problem code 2907 and patient code 3165 capture the reportable event of dart detachment and device fragments in patient.An examination of the returned capio slim suture capturing device and mesh assembly was performed.No damage was noted to the capio slim suture capturing device.On the mesh assembly, no damage was noted to the mesh material itself.The leader loops on the blue/white dilator were cut.On the blue/white dilator, no damage was noted; the dart and suture were intact.On the blue dilator, the suture was broken in the area where the dart interacts with the carrier, confirming the complaint.Furthermore, the carrier extended and retracted into the cage with no issue.The cage of the capio slim suture capturing device was removed for further inspection; the portion of the detached suture containing the dart was not found inside of the cage.The most probable cause for the event of dart detachment/suture breakage is design inadequate for purpose, which indicates that problems were traced to design/design features of the device that do not support or do interfere with the intended purpose of the device.An investigation was opened to address the failure of the dart detachment/suture broken issue.The investigation determined that the design of the carrier allows the fiber portion of the suture to interact with the sharp edge of the carrier, resulting in the suture severing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was used during a pelvic floor repair procedure performed on (b)(6), 2018.According to the complainant, during the procedure, the dart detached from the suture during the deployment and it remained inside the patient.Reportedly, the suture was not tensioned during deployment of the suture.The procedure was completed with another uphold lite with capio slim.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be stable.Should additional relevant details become available; a supplemental report will be submitted.

• Brand Name: UPHOLD LITE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8265471
• MDR Text Key: 133709919
• Report Number: 3005099803-2019-00143
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

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 Expiration Date: 07/16/2021
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0022388498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Manufacturer Received: 12/27/2018
• Initial Date FDA Received: 01/21/2019
• Supplement Dates Manufacturer Received: 02/21/2019
• Supplement Dates FDA Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other