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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 Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/25/2019
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 an uphold lite procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the dart did not penetrate tissue for two to three times.When the suture was caught and was being pulled from the anatomy, the dart detached from the suture.Reportedly, the dart did not detach into the patient.In addition, it was reported that 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 were no patient complications 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 uphold lite procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the dart did not penetrate tissue for two to three times.When the suture was caught and was being pulled from the anatomy, the dart detached from the suture.Reportedly, the dart did not detach into the patient.In addition, it was reported that 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 were no patient complications as a result of the event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Blocks f10 and h6: device code of 2907 captures the reportable event of dart detachment.Block g1: manufacturing site although the most recent 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.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 it revealed that the dart was missing from the blue dilator.There was damage to the blue dilator and suture.A visual assessment of the delivery device was performed and no issues were noted.Functional assessment was performed and noted that the dart on the leg assembly with blue and white stripe dilator was loaded into the capio slim device and deployed into the cage with no issues.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 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, that 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 is in place to address the failure of the dart detachment/suture broken issue.
 
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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 Key8630230
MDR Text Key145746650
Report Number3005099803-2019-02590
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 06/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2019
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 Number0000061425
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2019
Date Manufacturer Received05/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight56
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