Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN Back to Search Results
Model Number M0068318170
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2018
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 was used during a uphold pelvic organ prolapse procedure performed on (b)(6) 2018.According to the complainant, during the procedure, on both sides of the patient, the dart detached from the uphold kit after deployment of the device.Reportedly, they have not found the dart and could not determine whether it was inside the capio slim or in the sacrospinous ligament.The procedure was completed with another uphold¿ lite with capio slim.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Analysis of the returned uphold lite with capio slim revealed that the suture on the blue with white stripe dilator was broken.The dart was located behind the cage of the capio slim.There was a small amount of suture attached to it.Analysis also revealed there was no damage to the capio slim suture capturing 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.However, the investigation concluded that the most probable cause for suture broke is manufacturing process design, because the design or validation of the manufacturing process was not sufficient to ensure the finished device met the intent of the design.An investigation concluded 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.The issue is under investigation and a correction has not yet been implemented.Based on the analysis that the dart was found in the capio cage.Blocks updated as the device was returned with the lot number 0000053680.
 
Event Description
It was reported to boston scientific corporation that an uphold lite with capio slim was used during a uphold pelvic organ prolapse procedure performed on (b)(6) 2018.According to the complainant, during the procedure, on both sides of the patient, the dart detached from the uphold kit after deployment of the device.Reportedly, they have not found the dart and could not determine whether it was inside the capio slim or in the sacrospinous ligament.The procedure was completed with another uphold lite with capio slim.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
The assigned complaint investigation conclusion code for this event is supplier manufacturing process design because the design or validation of a suppliers manufacturing process was not sufficient to ensure the finished device met the intent of the design.
 
Event Description
It was reported to boston scientific corporation that an uphold¿ lite with capio slim was used during a uphold pelvic organ prolapse procedure performed on (b)(6) 2018.According to the complainant, during the procedure, on both sides of the patient, the dart detached from the uphold kit after deployment of the device.Reportedly, they have not found the dart and could not determine whether it was inside the capio slim or in the sacrospinous ligament.The procedure was completed with another uphold¿ lite with capio slim.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UPHOLD¿ LITE
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
Manufacturer (Section D)
BOSTON SCIENTIFIC - MARLBOROUGH
100 boston scientific way
marlborough MA 01752
MDR Report Key7363626
MDR Text Key103238699
Report Number3005099803-2018-00696
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,Followup
Report Date 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/19/2020
Device Model NumberM0068318170
Device Catalogue Number831-817
Device Lot Number0000053680
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2018
Date Manufacturer Received07/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age71 YR
-
-