MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPO STANDARD FR4 5 FRENCH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Lot Number 60498231

Patient Problem Insufficient Information (4580)

Event Date 01/04/2024

Event Type  Injury  

Event Description

Issues with multiple catheters not allowing a wire to pass through or having a piece of plastic on the wire when removed from the package.Remaining catheters from this manufacturer were removed from hospital inventory and sent back to the manufacturer.Ref report: mw5150064.

• Brand Name: EXPO STANDARD FR4 5 FRENCH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 18485239
• MDR Text Key: 332666204
• Report Number: MW5150065
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/05/2024

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?: Yes
• Device Operator: Health Professional
• Device Lot Number: 60498231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 134 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White