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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC PERFORMA DIAGNOSTIC CATHETER

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MERIT MEDICAL SYSTEMS INC PERFORMA DIAGNOSTIC CATHETER Back to Search Results
Catalog Number 7503-21/B
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Vascular Dissection (3160)
Event Date 10/30/2016
Event Type  Injury  
Manufacturer Narrative
The suspect device is not expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
 
Event Description
Per received medwatch uf report # [mw5066026]: the account alleges that during a scheduled right coronary angiogram, the physician selectively cannulated the right coronary artery resulting in a spiral dissection of the coronary artery. The physician promptly placed four drug eluting stents within the coronary artery to treat the dissection. The patient tolerated the procedure well.
 
Manufacturer Narrative
The suspect device was not returned for evaluation. The complaint could not be confirmed and the root cause could not be determined. A review of the complaint database was performed and no similar complaints were found for this lot number. A review of the device history record was performed and no exception documents were found.
 
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Brand NamePERFORMA DIAGNOSTIC CATHETER
Type of DeviceDIAGNOSTIC CATHETER
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC
1600 merit parkway
south jordan UT 84095
Manufacturer (Section G)
MERIT MEDICAL SYSTEMS INC
1600 merit parkway
south jordan UT 84095
Manufacturer Contact
casey hughes ms, cqe
1600 merit parkway
south jordan, UT 84095
8013164932
MDR Report Key6288449
MDR Text Key66114037
Report Number3011642792-2017-00003
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K943739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2019
Device Catalogue Number7503-21/B
Device Lot NumberI977795
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/18/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/30/2017 Patient Sequence Number: 1
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