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

Model Number H7493941816250

Device Problems Difficult or Delayed Positioning (1157); Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2023

Event Type  malfunction  

Event Description

Coronary stent being placed with difficulty inflating the attached device balloon.Unable to fully inflate balloon, and had blood return noted in the catheter indicating possible hole or rupture to balloon.Stent was deployed without incident, device balloon was removed.

• Brand Name: CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA 01752
• MDR Report Key: 16701418
• MDR Text Key: 313007850
• Report Number: MW5116438
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493941816250
• Device Catalogue Number: H7493941816250
• Device Lot Number: 29737068
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic