MAUDE Adverse Event Report: ST. JUDE MEDICAL ENGAGE; INTRODUCER, CATHETER

Model Number C408509

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2020

Event Type  malfunction  

Event Description

It was discovered that the introducer sheath did not have a hole in the end for the introducer or the wire to go through.Introducer sheath was replaced and procedure was completed without delay or harm to the patient.

• Brand Name: ENGAGE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10476083
• MDR Text Key: 205110088
• Report Number: 10476083
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: C408509
• Device Catalogue Number: C408509
• Device Lot Number: 7389143
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Weight: 66