MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS CORONARY STENT SYSTEM; CORONARY DRUG-ELUTING STENT

Model Number 3.00 X12MM

Device Problems Break (1069); Sticking (1597); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 11/28/2015

Event Type  malfunction  

Event Description

While using a cougar wire, inserting this promus stent, the stent stuck to the wire.They tried to removed the wire, it would not pull back.They tried to push the wire forward, it would not go forward.They wet the wire several times, but the stent would not go forward or backwards.They took the hemostat and pulled on the stent catheter while the physician held the wire.The stent catheter broke.Then while the physician held the wire again, they pulled, with the hemostats, on the actual stent; and removed it from the wire.We then proceeded with a new stent and completed the procedure.

• Brand Name: PROMUS CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marina bay customer fulfillment center; 500 commander shea blvd.; quincy MA 02171
• MDR Report Key: 6002553
• MDR Text Key: 56565687
• Report Number: 6002553
• 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: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/08/2017
• Device Model Number: 3.00 X12MM
• Device Lot Number: 18314314
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 98