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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 DS2C021
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Vascular Dissection (3160)
Date of Event 03/19/2021
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
It was reported that during implant of the left ventricular (lv) lead, dissection of the coronary sinus by the catheter occurred.The procedure was ended and no lv lead was implanted.No intervention was performed to treat the dissection; the patient was stable and will continue to be monitored.There were no adverse consequences.
 
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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 Key11605630
Report Number2017865-2021-13504
Device Sequence Number19738421
Product Code DQY
UDI-Device Identifier05415067004208
UDI-Public05415067004208
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
K130257
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/01/2021
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 Date11/30/2023
Device Model NumberDS2C021
Device Catalogue NumberDS2C021
Device Lot Number7760083
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 03/19/2021
Initial Report FDA Received Date04/01/2021
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 Required Intervention;
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