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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN Back to Search Results
Model Number M0068318170
Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/15/2019
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 a vaginal vault suspension procedure performed on (b)(6) 2019.According to the complainant, during deployment of the device during the procedure, the dart detached from the suture when fired.Reportedly, it occurred outside the patient.The procedure was completed with another uphold lite with capio slim device.There was no harm reported as a result of this 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 a vaginal vault suspension procedure performed on (b)(6) 2019.According to the complainant, during deployment of the device during the procedure, the dart detached from the suture when fired.Reportedly, it occurred outside the patient.The procedure was completed with another uphold lite with capio slim device.There was no harm 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 code of 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.An examination of the returned capio slim suture capturing device and mesh assembly was performed.On the capio slim suture capturing device, the cage appeared to have been damaged, likely by the user's tool.However, a functional assessment for the capio slim suture capturing device revealed that the carrier could be extended and retracted into the cage with no issue.Furthermore, on the mesh assembly, no damage was noted to the mesh material itself.The leader loops were intact.On the blue/white dilator, the suture was broken at the dilator tip.On the blue dilator, the suture was broken approximately midway, but tied back together.There were tool marks present on the blue dilator.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.It is likely that operational factors, such as user handling/technique, patient anatomy, and mesh placement/adjustment, contributed to the reported complaint.Therefore, the investigation concluded that the most probable cause for this event is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on event.
 
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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 Key8334212
MDR Text Key136010665
Report Number3005099803-2019-00609
Device Sequence Number1
Product Code OTP
UDI-Device Identifier08714729839200
UDI-Public08714729839200
Combination Product (y/n)N
PMA/PMN Number
K122459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/11/2020
Device Model NumberM0068318170
Device Catalogue Number831-817
Device Lot Number0000062156
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2019
Date Manufacturer Received03/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age65 YR
Patient Weight70
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