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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER; CATHETER, PERCUTANEOUS
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ABBOTT CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER; CATHETER, PERCUTANEOUS Back to Search Results
Model Number DS2C019
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Vascular Dissection (3160)
Date of Event 11/22/2019
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
During implant, it was reported that there was difficulty inserting the catheter into the coronary sinus due to air bubbles.A different delivery catheter was used but it was discovered that the use of the catheter had led to a dissection of the coronary sinus.The left ventricular (lv) lead was not implanted.The patient was in stable condition following the procedure.
 
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Brand Name
CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
MDR Report Key9453947
Report Number2017865-2019-17814
Device Sequence Number11315003
Product Code DQY
UDI-Device Identifier05415067004185
UDI-Public05415067004185
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K130257
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/11/2019
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? No
Operator of Device Health Professional
Device Expiration Date06/30/2022
Device Model NumberDS2C019
Device Lot Number7113763
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/22/2019
Initial Report FDA Received Date12/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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