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

Catalog Number 7560-23/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Aortic Dissection (2491)

Event Date 01/05/2015

Event Type  Injury  

Event Description

The physician reported that during a diagnostic coronary angiography, the common trunk of the left coronary artery became locally dissected.The physician stated that the catheter is too aggressive and had bad torque.No further harm or injury to the patient was reported.

Manufacturer Narrative

Device evaluation: no device is expected to be returned for investigation.Because the unit was not returned, the root cause could not be determined.The device history record was reviewed and no exception documents were found.All inprocess testing data was reviewed and found to be in specification.The complaint database was reviewed and one similar complaint for this lot number was found.If the device is returned in the future, this investigation will be reopened and a follow up submitted.

• 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: 4469164
• MDR Text Key: 5183061
• Report Number: 1628221-2015-00001
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K943739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Catalogue Number: 7560-23/A
• Device Lot Number: I685723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2015
• Initial Date FDA Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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
• Patient Outcome(s): Life Threatening; Required Intervention