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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO SLIM; HOLDER, NEEDLE, GASTROENTEROLOGIC
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BOSTON SCIENTIFIC CORPORATION CAPIO SLIM; HOLDER, NEEDLE, GASTROENTEROLOGIC Back to Search Results
Model Number M0068318250
Device Problems Retraction Problem (1536); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2023
Event Type  malfunction  
Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of carrier retraction problem.
 
Event Description
It was reported to boston scientific corporation that a capio slim was used during a sacrospnious ligament fixation procedure in the vagina, performed on (b)(6) 2023.During the procedure, the cage would not catch the needle and the carrier would not fully retract.It was unknown if/how the procedure was completed at this time.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of carrier retraction problem.Block h10: the returned capio slim device was analyzed, and a visual evaluation noted that the carrier was kinked/bent and was not fully retracted.A dimensional inspection determined that the spring catch was out of specification.A functional evaluation noted that, after deploying the device, the cage was unable to catch the suture.The carrier experienced friction at the time of retraction but was able to retract.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 information available and analysis results, the reported allegation of carrier retraction problem and failure to catch needle was confirmed.Furthermore, it was also found through analysis that the device sling carrier was bent/kinked; further investigation is in progress to address this observation.A conclusion code of cause traced to device design was assigned to this investigation.Block h11: block b5 has been updated based on the additional information received on january 16, 2024.
 
Event Description
It was reported to boston scientific corporation that a capio slim was used during a sacrospnious ligament fixation procedure in the vagina, performed on (b)(6) 2023.During the procedure, the cage would not catch the needle and the carrier would not fully retract.It was unknown if/how the procedure was completed at this time.There were no patient complications reported as a result of this event.Additional information: the procedure was completed with another capio slim device.
 
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Brand Name
CAPIO SLIM
Type of Device
HOLDER, NEEDLE, GASTROENTEROLOGIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS  
Manufacturer Contact
farshad fahimi
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key18490642
MDR Text Key332603526
Report Number2124215-2023-74928
Device Sequence Number1
Product Code FHQ
Combination Product (y/n)N
Reporter Country CodeUS
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 02/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM0068318250
Device Catalogue Number831-825
Device Lot Number0031942748
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/10/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2023
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 SexFemale
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