MAUDE Adverse Event Report: MERIT MEDICAL SYSTEM, INC. MERIT MEDICAL SYSTEM, INC.; ANGIOGRAPH

Model Number 59038UAC

Device Problems Kinked (1339); Difficult to Remove (1528)

Patient Problem Injury (2348)

Event Date 09/22/2017

Event Type  Injury  

Event Description

When the catheter was being removed it kinked on itself which made removal of the catheter difficult and subsequently caused injury to the right external iliac artery which required stenting to repair.

• Brand Name: MERIT MEDICAL SYSTEM, INC.
• Type of Device: ANGIOGRAPH
• Manufacturer (Section D): MERIT MEDICAL SYSTEM, INC.; little rock AR 72205
• MDR Report Key: 6913985
• MDR Text Key: 88235135
• Report Number: MW5072590
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 59038UAC
• Device Lot Number: E955797
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 93