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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CAPIO SLIM; OPEN ACCESS SUTURE CAPTURING DEVICE

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BOSTON SCIENTIFIC CAPIO SLIM; OPEN ACCESS SUTURE CAPTURING DEVICE Back to Search Results
Catalog Number MOO6 8318260
Device Problem Detachment Of Device Component (1104)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 04/20/2017
Event Type  Injury  
Event Description
Metal tip of capio suture fire device dislodged into pelvis during surgery requiring a laparotomy to find and remove.This resulted in performing open procedure, increased length of procedure and anesthesia time.
 
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Brand Name
CAPIO SLIM
Type of Device
OPEN ACCESS SUTURE CAPTURING DEVICE
Manufacturer (Section D)
BOSTON SCIENTIFIC
300 boston scientific way
marlborough MA 01752 1234
MDR Report Key6587686
MDR Text Key75933963
Report Number6587686
Device Sequence Number1
Product Code FHQ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/02/2017
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 Expiration Date09/16/2019
Device Catalogue NumberMOO6 8318260
Device Lot Number19730190
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/02/2017
Distributor Facility Aware Date04/20/2017
Device Age NA
Event Location Hospital
Date Report to Manufacturer05/02/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/10/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age42 YR
Patient Weight66
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