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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 Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/22/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Manufacturing site: although the current manufacturing site for uphold lite is boston scientific in (b)(4), the reported lot involved in this complaint was manufactured by: freudenberg medical, (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) 2019.According to the complainant, during the procedure, the dart detached from the suture and stuck inside the capio slim head.The procedure was then completed with a different device.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
 
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) 2019.According to the complainant, during the procedure, the dart detached from the suture and stuck inside the capio slim head.The procedure was then completed with a different device.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
 
Manufacturer Narrative
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: (b)(4).A capio device and a mesh assembly were received.Analysis found no issues with the capio slim delivery device.For the mesh assembly, the sutures appeared to be broken in the area where the dart interacts with the carrier, confirming the complaint.The pieces of the sutures containing the darts were not returned.Futhermore, the cut on the suture with the blue dilator was clean cut as if it was cut with something sharp.The suture on blue with white dilator was frayed where the suture was cut.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.However, an investigation was opened to address the failure of dart detachment/suture breakage.That investigation determined that the suture was broken in the area where the suture interacts with the carrier.Therefore, the most probable cause for this event 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.
 
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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 Key8440592
MDR Text Key139464640
Report Number3005099803-2019-01281
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 06/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2019
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 Number62158
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2019
Date Manufacturer Received06/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age63 YR
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