MAUDE Adverse Event Report: BOSTON SCIENTIFIC CAPIO SUTURE DEVICE

Lot Number 74A1500125

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/28/2016

Event Type  Injury  

Event Description

Patient was having a posterior urethroplasty performed.The surgeon was using a capio suture device with a capio suture which has a sh needle at one end of the suture with a separate 2.5mm at the other end of 36 inch suture.The bullet became detached from the suturing device while in the patient.The surgeons were not able to retrieve the small bullet from the scar tissue area because of potential harm to the patient.

• Brand Name: CAPIO SUTURE DEVICE
• Type of Device: CAPIO SUTURE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5662231
• MDR Text Key: 45494628
• Report Number: MW5062327
• Device Sequence Number: 1
• Product Code: MFJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 74A1500125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 88