MAUDE Adverse Event Report: BOSTON SCIENTIFIC CAPIO SLIM SUTURE CAPTURE DEVICE; CAPIO SUTURE SPEAR HEAD NEEDLE

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Unknown (for use when the patient's condition is not known) (2202)

Event Date 02/12/2015

Event Type  malfunction  

Event Description

Capio suture needle came off suture after device was activated.X-ray taken to confirm location of spear head (needle) at the end of the case and the object was confirmed to be in the perineum by the surgeon.Surgeon chose not to try to remove the capio because it would cause more harm than leaving it in place.Packaging not saved by operating room team.

• Brand Name: CAPIO SLIM SUTURE CAPTURE DEVICE
• Type of Device: CAPIO SUTURE SPEAR HEAD NEEDLE
• Manufacturer (Section D): BOSTON SCIENTIFIC; 300 boston scientific way; marlborough MA 01752 123
• MDR Report Key: 4597972
• MDR Text Key: 5470544
• Report Number: 4597972
• 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: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: REF # 833-123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2015
• Distributor Facility Aware Date: 02/12/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR