MAUDE Adverse Event Report: BOSTON SCIENTIFIC PT2 LIGHT SUPPORT GUIDEWIRE

Model Number PT2

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/10/2018

Event Type  Injury  

Event Description

It was discovered that the hydrophilic portion of the pt2 wire had broken off and the foreign body was retained.Due to medical condition, pt is not a candidate for surgical intervention.However, the wire was visualized as being trapped behind two layers of stent struts.Interventional cardiologist re-crossed the stent strut and performed a kissing balloon angioplasty to further compress the stent strut into the retained portion of the wire to prevent embolization.

• Brand Name: PT2 LIGHT SUPPORT GUIDEWIRE
• Type of Device: PT2 LIGHT SUPPORT GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA 01752
• MDR Report Key: 7193930
• MDR Text Key: 97498680
• Report Number: MW5074574
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/11/2018

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: 10/17/2019
• Device Model Number: PT2
• Device Catalogue Number: H74938931010
• Device Lot Number: 21268033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2018
• 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: 59 YR