MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC PT2 MODERATE SUPPORT; GUIDEWIRE

Lot Number 20898499

Device Problems Break (1069); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/09/2018

Event Type  No Answer Provided  

Event Description

During a coronary intervention, the tip of the coronary wire broke off into the patient's coronary.Due to the size of the vessel the tip was unable to be retrieved via snare.The tip migrated into a non-essential branch while trying to retrieve it.Wire fragment was left in the branch due to inability to retrieve.

• Brand Name: BOSTON SCIENTIFIC PT2 MODERATE SUPPORT
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 7369321
• MDR Text Key: 103658908
• Report Number: MW5076099
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 20898499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2018
• 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 Age: 62 YR
• Patient Weight: 111