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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH 2-0 POLYPROPYLENE SUTURE; ENDOSCOPIC TISSUE APPROXIMATION DEVICE
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APOLLO ENDOSURGERY OVERSTITCH 2-0 POLYPROPYLENE SUTURE; ENDOSCOPIC TISSUE APPROXIMATION DEVICE Back to Search Results
Model Number PLY-G02-020-APL
Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/04/2024
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that an overstitch 2-0 polypropylene suture was used on an unknown procedure to treat obesity performed on (b)(6) 2024.During the procedure, two sutures tore with minimal pressure when trying to pass through the tissue.This resulted in the procedure being delayed and causing the account to change new sutures back-to-back.The procedure was able to be completed using another of the same device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf code: a0401 is being used to capture the reportable event of suture break.
 
Event Description
It was reported to boston scientific corporation that an overstitch 2-0 polypropylene suture was used on an unknown procedure to treat obesity performed on (b)(6) 2024.During the procedure, two sutures tore with minimal pressure when trying to pass through the tissue.This resulted in the procedure being delayed and causing the account to change new sutures back-to-back.The procedure was able to be completed using another of the same device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf code a0401 is being used to capture the reportable event of suture break.Block h10: with all the available information boston scientific concludes that the reported event of suture break, was unable to be confirmed.Device analysis: a suture was returned without the detached anchor.The suture material returned has the typical appearance of the suture pulled out of the anchor as the suture end is flattened.The suture did not break; however, was pulled out of the anchor.Labeling review: a labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Risk review a risk review of the overstitch 2-0 polypropylene suture was completed and confirmed that the event of break was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Device history record (dhr) review a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Investigation conclusion for the as reported failure of break has not been visually confirmed as the suture was pulled out of the anchor, not broken.This event is catalogued as "no problem detected" since the problem cannot be confirmed.This investigation is assigned a most probable conclusion code of "adverse event related to procedure".The conclusion is acceptable because, after the product analysis, it was found that the suture was pulled out of the anchor.Also, the evidence from the product record review did not identify a potential product quality issue and the adverse event occurred during the procedure but the device had no influence on the event.
 
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Brand Name
OVERSTITCH 2-0 POLYPROPYLENE SUTURE
Type of Device
ENDOSCOPIC TISSUE APPROXIMATION DEVICE
Manufacturer (Section D)
APOLLO ENDOSURGERY
1120 s. capital of texas hwy
bldg 1 suite 300
austin TX 78746
Manufacturer (Section G)
APOLLO ENDOSURGERY COSTA RICA S.R.L
alajuela, 02
CS  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key18842108
MDR Text Key337194800
Report Number3005099803-2024-00787
Device Sequence Number1
Product Code OCW
UDI-Device Identifier10811955020732
UDI-Public10811955020732
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191439
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPLY-G02-020-APL
Device Lot Number23SE5966
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/03/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/24/2023
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 Age29 YR
Patient SexFemale
Patient Weight99 KG
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