MAUDE Adverse Event Report: MERIT MEDICAL ANGIOGRAPHIC CATHETER PIGTAIL CATHETER

Catalog Number	7602-20M100SH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
As staff prepared a marker pigtail catheter for a tavr procedure, the hub of the catheter completely came off the line.The same issue occurred with another catheter.A third catheter was selected from a different lot without any issues.

• Brand Name: ANGIOGRAPHIC CATHETER PIGTAIL CATHETER
• Common Device Name: ANGIOGRAPHIC CATHETER PIGTAIL CATHETER
• Manufacturer (Section D): MERIT MEDICAL; south jordan UT 84095
• MDR Report Key: 7193922
• Report Number: MW5074571
• Device Sequence Number: 896257
• Product Code: DQO
• UDI-Device Identifier: 00884450002544
• UDI-Public: (01)00884450002544
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 7602-20M100SH
• Device Lot Number: E1239598
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 89