MAUDE Adverse Event Report: BOSTON SCIENTIFIC COMET PRESSURE GUIDEWIRE; COMET PRESSURE GUIDEWIRE 0.014IN X 182CM FFR L

Model Number H7495551110

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/28/2019

Event Type  Injury  

Event Description

While performance a left heart catheterization via a right radial approach, the wire fractured in the coronary artery.With assistance from interventional radiology the majority of the device was removed; however, it was noted a 1cm long fragment of fracture wire remained.After 6 hours of fluoroscopy and interventional time spent attempting to retrieve all elements of the wire, it was evaluated that the patient was a low risk for encountering complications from this remaining wire and the decision was made to leave the wire in place.The patient remained in observation in the icu overnight for evaluation and encountered no further occurrences related to this event, at this time.

• Brand Name: COMET PRESSURE GUIDEWIRE
• Type of Device: COMET PRESSURE GUIDEWIRE 0.014IN X 182CM FFR L
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 8367626
• MDR Text Key: 137187059
• Report Number: 8367626
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• 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: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7495551110
• Device Lot Number: 22235597
• 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: 02/08/2019
• Distributor Facility Aware Date: 02/05/2019
• Event Location: Hospital
• 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: 72 YR
• Patient Weight: 82