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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; CPS 135
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; CPS 135 Back to Search Results
Model Number CPS 135
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 10/29/2020
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
Related manufacturer reference number: 2017865-2020-25250.It was reported that on (b)(6) 2020 a dissection of the coronary sinus occurred during a left ventricular lead implantation.It was noted to be due to the introducer and guidewire.The physician decided to abandon the implant of the lead.The patient's condition was stable throughout the procedure and after.
 
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Type of Device
CPS 135
Manufacturer Contact
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key11127983
MDR Text Key225491529
Report Number2017865-2020-25251
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 01/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCPS 135
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
COURIER 0.14 GUIDE WIRE
Patient Outcome(s) Other;
Patient Age77 YR
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