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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL INTRODUCER UNKNOWN INTRODUCER, CATHETER

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ST. JUDE MEDICAL INTRODUCER UNKNOWN INTRODUCER, CATHETER Back to Search Results
Device Problems Kinked (1339); Difficult To Position (1467)
Patient Problem Vascular Dissection (3160)
Event Date 02/13/2018
Event Type  Injury  
Manufacturer Narrative
Product evaluation: the reported event of a "kink in the anatomy of the device" could not be confirmed. 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. The ultimum hemostasis introducer sheath instruction for use (ifu) states that the user should advance the dilator/sheath assembly with a twisting motion to avoid damage to the sheath or vessel. The ultimum hemostasis introducer sheath instruction for use (ifu) cautions that individual patient anatomy and physician technique may require procedural variations.
 
Event Description
When attempting a cardiomems implant, puncture was not successful on both left and right femoral veins. The puncture sites were pre-dilated with a 6f, 7f, and 9f non-abbott products. A 12 f ultimum introducer was used on each side for the bilateral punctures. The patient's anatomy complicated access and dissections were caused on both sides. Ultrasound was used for femoral venous access. The vessels were kinky and narrow and it cannot be confirmed that the introducers are the reason for the dissections. Please reference 3005334138-2018-00108 for other mdr.
 
Manufacturer Narrative
Product evaluation: an event of dissection could not be confirmed. 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
When attempting a cardiomems implant, puncture was not successful on both left and right femoral veins. The puncture sites were pre-dilated with a 6f, 7f, and 9f non-abbott products. A 12 f ultimum introducer was used on each side for the bilateral punctures. The patient's anatomy complicated access and dissections were caused on both sides. Ultrasound was used for femoral venous access. The vessels were kinky and narrow and it cannot be confirmed that the introducers are the reason for the dissections.
 
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Brand NameINTRODUCER UNKNOWN
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
MDR Report Key7441304
MDR Text Key105847079
Report Number3005334138-2018-00109
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K001346
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2018
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 Treatment Data
Date Received: 04/18/2018 Patient Sequence Number: 1
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