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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 Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).(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 (tm) lite w/ capio slim was used during an anterior prolapse repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the doctor noticed that the mesh split into two pieces on the patient's right sacrospinous ligament.Subsequently, the physician decided to remove all the device material from the patient.The procedure was completed with a different device.The condition of the patient after the procedure was reported to be stable.
 
Event Description
It was reported to boston scientific corporation that an uphold (tm) lite w/ capio slim was used during an anterior prolapse repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the doctor noticed that the mesh split into two pieces on the patient's right sacrospinous ligament.Subsequently, the physician decided to remove all the device material from the patient.The procedure was completed with a different device.The condition of the patient after the procedure was reported to be stable.
 
Manufacturer Narrative
(b)(6).Blocks f10 and h6: problem code 4008 captures the reportable event of mesh split into two pieces.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: freudenberg medical, 2301 centennial boulevard, jefferson in, 47130 usa.Block h10: an examination of the returned capio slim suture capturing device and mesh was performed.No damage was noted to the capio slim suture capturing device.Only a portion of the mesh material itself was returned.The mesh was torn, confirming the complaint.There was residue on the mesh, indicating signs of use.Furthermore, the carrier extended and retracted into the cage with no issue.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.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.
 
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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 Key8201840
MDR Text Key131587920
Report Number3005099803-2018-62229
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 03/19/2019
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 Date03/05/2020
Device Model NumberM0068318170
Device Catalogue Number831-817
Device Lot Number0000058081
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2019
Initial Date Manufacturer Received 11/29/2018
Initial Date FDA Received12/27/2018
Supplement Dates Manufacturer Received02/22/2019
Supplement Dates FDA Received03/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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