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

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.

• 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 Key: 6587686
• MDR Text Key: 75933963
• Report Number: 6587686
• Device Sequence Number: 1
• Product Code: FHQ
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Date: 09/16/2019
• Device Catalogue Number: MOO6 8318260
• Device Lot Number: 19730190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2017
• Distributor Facility Aware Date: 04/20/2017
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 66