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 No Consequences Or Impact To Patient (2199)

Event Date 12/13/2018

Event Type  malfunction  

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

It was reported to boston scientific corporation that an uphold lite with capio slim device was used during an anterior prolapse repair with uphold lite procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the dart was unable to penetrate tissue during the first deployment on the patient's right side.When the device was pulled out, it was noticed that the dart detached from the suture and the dart was left inside the capio device.The nurse then took the dart out from the capio device and discarded it with the mesh.Reportedly, the suture was pulled back and tensioned along the capio handle during the deployment.The procedure was completed with another uphold lite with capio slim.There was no serious injury reported as a result of the event.The patient's condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was used during an anterior prolapse repair with uphold lite procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the dart was unable to penetrate tissue during the first deployment on the patient's right side.When the device was pulled out, it was noticed that the dart detached from the suture and the dart was left inside the capio device.The nurse then took the dart out from the capio device and discarded it with the mesh.Reportedly, the suture was pulled back and tensioned along the capio handle during the deployment.The procedure was completed with another uphold lite with capio slim.There was no serious injury reported as a result of the event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

F10 and h6: problem code of 2907 for captures the reportable event of dart detachment.G1: 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, no damaged was noted to the mesh material itself.The leader loops were intact.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.The portion of the detached suture containing the dart was returned.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 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.

• 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: 8227538
• MDR Text Key: 132412550
• Report Number: 3005099803-2019-00022
• 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: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 12/27/2018
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 02/05/2019
• Supplement Dates FDA Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR