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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND SENTRANT INTRODUCER SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number UNK-CV-SR-SENTRANT
Device Problems Fluid Leak (1250); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic conducted a post market clinicai follow-up (pmcf) survey to seek out potential new risks and assess performance of the sentrant device. The exact size of the device is unknown. Survey results from a interventional cardiologist in practice 18 years, who has used the device 35 times in total of which all of those times were in the last 12 months. During use of the sentrant, the following complication was encountered in the last 12 months ; blood loss/bleeding (2 times) , vascular trauma (2 times) (e. G dissection with rupture, perforation or tear). The blood loss/ bleeding & vascular trauma events were assessed by the physician as related to the device itself on one occasion each. Of the above complications reported, some of these are listed as having been reported to medtronic previously. Due to limited information these are included in reporting. The physician assessed the blood loss/bleeding event as not at all concerning and the vascular trauma event as somewhat concerning. It was reported the physician knew these were potential complications as noted in the instructions for use (ifu) prior to the procedure. For the adverse events that were deemed device related, it was said the sheath was defective. The physician had the opinion that the sentrant performed as expected when it was used and according to instructions for use (ifu). No further information has or will be provided.
 
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Brand NameSENTRANT INTRODUCER SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway,ie
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway,ie
EI
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key11847232
MDR Text Key251422925
Report Number9612164-2021-01951
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 05/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNK-CV-SR-SENTRANT
Device Catalogue NumberUNK-CV-SR-SENTRANT
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 Received05/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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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