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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

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COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER Back to Search Results
Catalog Number 519650
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/06/2024
Event Type  Injury  
Event Description
According to the available information when placing the dynamic anchor, the loop of the suture was lost in his dissection plane and could not be retrieved and had to cut the suture.A new sling was placed successfully.
 
Manufacturer Narrative
The lot number was reviewed for complaint trend, non-conforming report, and capa.No ncs nor capa's were identified in veeva.There were several complaints identified against this lot; however, with various failure modes.Therefore, this is not considered a trend.Devices met specification prior to release.
 
Manufacturer Narrative
A partial altis sling was received for evaluation.Examination of the sling revealed straight edges in a ¿v¿ formation, indicating the static end of the mesh most likely was cut with a sharp instrumentation for removal.Examination of the detached dynamic suture revealed that the dynamic anchor, tensioner and suture loop were detached from the suture and were not returned with the device.Blood residue was noted on the mesh.The information received indicated that during implantation of the dynamic anchor, the suture loop was lost in the dissection plane which required the physician to cut the sling in order to remove it.Based on the information received and review of the returned components, quality concluded that it was a use error.Another sling was placed as per ifu and the outcome was successful.A review of the device history record by the contract manufacturer confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
 
Event Description
According to the available information when placing the dynamic anchor, the loop of the suture was lost in his dissection plane and could not be retrieved and had to cut the suture.A new sling was placed successfully.
 
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Brand Name
ALTIS SINGLE INCISION SLING SYSTEM
Type of Device
FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
Manufacturer (Section D)
COLOPLAST A/S
1 holtedam humlebaek, dk 3050
humlebaek 3050
DA  3050
Manufacturer Contact
usbes brian schmidt
1601 west river road n
minneapolis, MN 55411
MDR Report Key18841790
MDR Text Key336956313
Report Number2125050-2024-00361
Device Sequence Number1
Product Code PAH
UDI-Device Identifier05708932467407
UDI-Public05708932467407
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/17/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number519650
Device Lot Number9066450_5196502400
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/05/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/17/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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