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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 03/14/2019
Event Type  Injury  
Manufacturer Narrative
The event date was approximated to the bsc aware date as there was no event date reported.(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 procedure performed on an unknown date.According to the complainant, during the procedure, the suture broke during implantation.It was not reported if the dart was removed from the patient and/or how it was removed.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
The event date was approximated to the bsc aware date as there was no event date reported.Problem code 2907 captures the reportable event of dart detachment.An examination of the returned uphold lite with capio slim was performed.The suture was cut/detached from the blue and white dilator at the distal end of the dilator.There was visible damage to the dilator and the frayed suture could be seen through the dilator material.The detached section was not returned.No other damage to the mesh assembly was noted.There was some residue in the protective sleeves.Blue dilator, protective sleeves, leader loops and mesh were intact.A visual inspection of the capio slim device was conducted and there was some residue and signs of use on the carrier.No other abnormalities were noted.In addition, a functional test was performed and no issues were noted during deployment or retraction of the carrier.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.Based on the condition of the returned device, it is probable that operational factors, such as the user handling/technique and patient anatomy, resulted in the user encountering difficulty during the procedure and subsequently damaging the distal end of the dilator and detaching the suture and dart.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.
 
Event Description
It was reported to boston scientific corporation that an uphold lite with capio slim device was used during a procedure performed on an unknown date.According to the complainant, during the procedure, the suture broke during implantation.It was not reported if the dart was removed from the patient and/or how it was removed.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.
 
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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 Key8424592
MDR Text Key138919411
Report Number3005099803-2019-01143
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 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/06/2021
Device Model NumberM0068318170
Device Catalogue Number831-817
Device Lot Number22904322
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2019
Date Manufacturer Received03/28/2019
Patient Sequence Number1
Patient Outcome(s) Other;
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