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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC CARDIOVASCULAR SENTRANT INTRODUCER SHEATH INTRODUCER, CATHETER

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MEDTRONIC CARDIOVASCULAR SENTRANT INTRODUCER SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number SENSH1628W
Device Problems Inability to Irrigate (1337); Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/16/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A sentrant sheath was used as a conduit for an unknown device during an endovascular procedure. It was reported during the index procedure after the 16-fr delivery system was inserted, angiography could not be performed. Contrast solution could not be either pushed or pulled using a syringe at the side port of the sheath and a kink was observed on the sheath. The side port stopcock lever was used in the normal manner. Before the delivery system was inserted it was noted that contrast could be pushed/pulled by a syringe in the usual manner. The procedure was completed using a 18-fr sheath. As per the physician, the cause of the event is device related. No additional clinical sequelae were reported and the patient is fine.
 
Manufacturer Narrative
Device evaluation summary: a slight bend was observed on the sheath. There was no damage or kink evident to the side leg tubing. The sheath was flushed with a 16fr applier loaded; no abnormalities were noted flushing the sheath. No defect was observed on the sheath leg side leg tubing which would have hindered delivery of the contrast solution. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSENTRANT INTRODUCER SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
MEDTRONIC CARDIOVASCULAR
3576 unocal place
santa rosa CA 95403
Manufacturer (Section G)
MEDTRONIC CARDIOVASCULAR
3576 unocal place
santa rosa CA 95403
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
091708096
MDR Report Key7334599
MDR Text Key102320047
Report Number2953200-2018-00359
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K123990
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSENSH1628W
Device Catalogue NumberSENSH1628W
Device Lot Number00126991
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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