MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. IMPRESS; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 56538KA2

Device Problems Break (1069); Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/20/2016

Event Type  malfunction  

Event Description

Tip of impress angiographic catheter broke off in patient, but was retrieved immediately.

• Brand Name: IMPRESS
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit pkwy.; south jordan UT 84095
• MDR Report Key: 6089678
• MDR Text Key: 59513332
• Report Number: 6089678
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2016,09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2019
• Device Model Number: 56538KA2
• Device Catalogue Number: 56538KA2
• Device Lot Number: E955751
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR