Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER; CATHETER, PERCUTANEOUS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER; CATHETER, PERCUTANEOUS Back to Search Results
Model Number DS2C020
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Vascular Dissection (3160); Pericardial Effusion (3271)
Date of Event 11/26/2019
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 of the left ventricular (lv) lead, there was difficulty inserting the delivery cathether into the coronary sinus.It was noted that the catheter had caused a dissection leading to a pericardial effusion.The lv lead was not implanted; the patient was stable following the procedure and will continue to be monitored.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9531741
Report Number2182269-2019-00254
Device Sequence Number2313442
Product Code DQY
UDI-Device Identifier05415067004192
UDI-Public05415067004192
Combination Product (Y/N)N
Initial Reporter CountryGM
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) 12/30/2019
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 Date07/31/2022
Device Model NumberDS2C020
Device Lot Number7127419
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 12/14/2019
Initial Report FDA Received Date12/30/2019
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;
-
-