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

Model Number M0068318170

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been received for analysis.Upon 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

Note: this manufacturer report pertains to one of two devices used during the procedure.It was reported to boston scientific corporation that two uphold lite with capio slim devices were used during an uphold lite procedure performed on (b)(6) 2018.According to the complainant, during the procedure, for the first device, the dart was unable to penetrate tissue during the deployment on the patient's right side.When the device was pulled out, it was noticed that the dart detached from the suture.The detached piece was then left inside the patent.Subsequently, a second device was opened but the same issue occurred on the patient's left side, except that the dart did not fall off into the patient.Reportedly, sutures of both devices were not tensioned and were left free hanging during the deployment.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 at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Problem codes 2907 captures the reportable event of dart detachment.Manufacturing site although the current manufacturing site for uphold lite is boston scientific in spencer in, the reported lot involved in this complaint was manufactured by: freudenberg medical 2301 centennial boulevard jefferson in, 47130 usa.A visual examination was performed on the returned capio slim suture capturing device and mesh assembly.There was no damage noted to the capio slim suture capturing device.On the mesh assembly, only the side of the assembly containing the blue dilator was returned.Signs of use were noted; the leader loops were cut, and the mesh material itself was not returned.On the blue dilator, no damage was noted; the dart and suture were intact.A functional assessment for the capio slim suture capturing device was performed.The carrier could be extended and retracted into the cage with no issue.The cage of the capio slim suture capturing device was removed for further inspection; nothing was found inside of the cage.The investigation concluded that the most probable cause for the dart detachment/suture broken 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 "dart detachment/suture broken." per investigation, it was 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.The investigation is in the implementation phase and no further escalation is required.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

Note: this manufacturer report pertains to one of two devices used during the procedure.It was reported to boston scientific corporation that two uphold lite with capio slim devices were used during an uphold lite procedure performed on (b)(6) 2018.According to the complainant, during the procedure, for the first device, the dart was unable to penetrate tissue during the deployment on the patient's right side.When the device was pulled out, it was noticed that the dart detached from the suture.The detached piece was then left inside the patent.Subsequently, a second device was opened but the same issue occurred on the patient's left side, except that the dart did not fall off into the patient.Reportedly, sutures of both devices were not tensioned and were left free hanging during the deployment.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 at the conclusion of the procedure was reported to be stable.

• 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: 8196492
• MDR Text Key: 131407150
• Report Number: 3005099803-2018-62192
• 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: 02/27/2019

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: 04/04/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000061420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 02/03/2019
• Supplement Dates FDA Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 57