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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT CPS QUARTET INNER-SUB-ACU 135MEAN 59CM CATHETER, PERCUTANEOUS

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ABBOTT CPS QUARTET INNER-SUB-ACU 135MEAN 59CM CATHETER, PERCUTANEOUS Back to Search Results
Model Number DS2N026/59
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 07/13/2021
Event Type  Injury  
Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.

 
Event Description

During an implant procedure, a dissection of the coronary sinus was observed and was confirmed with fluoroscopy. It was suspected the dissection was due to the cps catheter. No intervention was required. The patient was stable.

 
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Brand NameCPS QUARTET INNER-SUB-ACU 135MEAN 59CM
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key12196084
MDR Text Key262427011
Report Number2017865-2021-26292
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK130252
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/20/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/20/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDS2N026/59
Device Catalogue NumberDS2N026-59
Device LOT Number7483006
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/13/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/15/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/20/2021 Patient Sequence Number: 1
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