MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PERFORMA ANGIOGRAPHIC CARDIOLOGY CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 7749-A0

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2014

Event Type  Injury  

Event Description

The user reported that, during an extremity angiogram, the pig tail end became disconnected from the rest of the catheter.The pig tail remained on the guide wire.Access was established in the left femoral artery and in the radial artery.The end of the catheter was snared and removed through the left femoral artery access.No further harm or injury to the pt was reported.

Manufacturer Narrative

Device evaluation: the device is expected to be returned.A follow up report will be sent when the evaluation has been completed.

• Brand Name: PERFORMA ANGIOGRAPHIC CARDIOLOGY CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; south jordan UT
• Manufacturer Contact: jerry mcphie ; 1600 west merit parkway; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 3839233
• MDR Text Key: 20972268
• Report Number: 1628221-2014-00003
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 7749-A0
• Device Lot Number: E523619
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SALINE; CONTRAST
• Patient Outcome(s): Required Intervention