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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 Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).(b)(6).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 procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after deployment of the device on the second side of the patient, it was noticed that the dart detached from the suture.Reportedly, a test was performed to reveal the presence or absence of the dart inside the patient by injecting physiological saline was but the test was unsuccessful.The procedure was completed with another uphold lite with capio slim.There were no patient complications as a result of this event.
 
Event Description
It was reported to boston scientific corporation that an uphold lite with capio slim device was used during a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after deployment of the device on the second side of the patient, it was noticed that the dart detached from the suture.Reportedly, a test was performed to reveal the presence or absence of the dart inside the patient by injecting physiological saline was but the test was unsuccessful.The procedure was completed with another uphold lite with capio slim.There were no patient complications as a result of this event.
 
Manufacturer Narrative
Device code 2907 captures the reportable event of dart detachment.Other: ansm incident report reference no (b)(4); submitted to ansm (agence nationale de securite du medicament et des produits de sante) by the healthcare facility.Investigation of the returned capio slim device and mesh assembly was performed.The capio slim device was able to be extended and retracted into the cage.The suture was broken on the blue/white dilator.It appeared to be broken near where the capio slim carrier interacts with the dart and suture.The dart was not returned.Furthermore, there was damage to the mesh assembly.There was tearing of the mesh and the leader loops and protective sleeves on both blue white dilator and blue dilator appeared to be cut.Based on the event, the issue of the dart detachment occurred while implanting the second side of the mesh, and the device was removed so a second device could be used.It is likely that the damage on the mesh assembly was caused during explanting of the device.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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.However, based on all gathered information, the investigation concluded that the most probable cause for the event of 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.That investigation found that the design of the carrier allows the fiber portion of the suture to interact with the sharp edge of the carrier, resulting in suture severing.Changes to the carrier design and process to decrease the edge sharpness were implemented on december 13, 2018; however, the complaint device was manufactured prior to implementation of these changes.
 
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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 Key8617462
MDR Text Key145296973
Report Number3005099803-2019-02398
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 09/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2021
Device Model NumberM0068318170
Device Catalogue Number831-817
Device Lot Number0022874840
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2019
Date Manufacturer Received08/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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