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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); Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/19/2019
Event Type  malfunction  
Manufacturer Narrative
The exact age of the patient is unknown, however, it was reported the patient was over 18 years.(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: (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) 2019.According to the complainant, during deployment of the device on the patient's left side during the procedure, the dart was unable to penetrate the tissue.It was then noticed that the dart detached from the suture but did not fall off into the patient's ligament.Reportedly, the suture was pulled back and was tensioned along the capio handle during the deployment.The procedure was completed with another of the uphold lite with capio slim device.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block a2: the exact age of the patient is unknown, however, it was reported the patient was over 18 years.(b)(4).Block 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: (b)(4) medical.Block h10: both the capio slim suture capturing device and uphold mesh assembly were returned.A visual assessment of the mesh assembly was performed and revealed that the dart was detached from the blue and white dilator and no other issues were noted.A visual assessment of the capio device was conducted and revealed that there was residue in the carrier arm channel.No other issues were noted.A functional test was performed and revealed that the dart was loaded and the carrier was extended into the cage.No issues were noted.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, it is 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.Therefore, the investigation concluded that the most probable cause for the dart detachment/suture broken issue 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.
 
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) 2019.According to the complainant, during deployment of the device on the patient's left side during the procedure, the dart was unable to penetrate the tissue.It was then noticed that the dart detached from the suture but did not fall off into the patient's ligament.Reportedly, the suture was pulled back and was tensioned along the capio handle during the deployment.The procedure was completed with another of the uphold lite with capio slim device.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
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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 Key8512557
MDR Text Key141925106
Report Number3005099803-2019-01735
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,foreig
Type of Report Initial,Followup
Report Date 05/13/2019
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 Date04/04/2020
Device Model NumberM0068318170
Device Catalogue Number831-817
Device Lot Number0000061422
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2019
Initial Date Manufacturer Received 03/21/2019
Initial Date FDA Received04/14/2019
Supplement Dates Manufacturer Received04/15/2019
Supplement Dates FDA Received05/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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