MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2.5 X 2.0 SYNERGY DES STENT BALLOON; CORONARY DRUG-ELUTING STENT

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2018

Event Type  malfunction  

Event Description

Boston scientific 3.5 x 20 synergy des stent balloon stuck to guidewire when deflated post stent deployment.Stent balloon also could not be removed through the guide catheter.Stent balloon, guidewire and guide catheter had to be removed together as a unit.No adverse patient events.Boston scientific was notified and all 3 components were returned for quality inspection.Procedure completed and no site complications.

• Brand Name: 2.5 X 2.0 SYNERGY DES STENT BALLOON
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• MDR Report Key: 7450216
• MDR Text Key: 106175779
• Report Number: 7450216
• Device Sequence Number: 1
• Product Code: NIQ
• 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: Other
• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: THE DEVICE MALFUNCTIONED DURING PERFORMANCE OF LEF
• Patient Age: 78 YR
• Patient Weight: 71