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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic conducted a post market clinical 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 vascular surgeon in practice 20 years, who has used the device 400 times in total over the last 3 years and 150 times in the last 12 months.During use of the sentrant, death events were encountered.The physician found the deaths very concerning.One of the death events was considered to be device related.The physician was previously aware that these events were in the ifu.No further information has or will be provided.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 9896874
• MDR Text Key: 185486106
• Report Number: 9612164-2020-01396
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K123990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 05/05/2020
• Supplement Dates FDA Received: 05/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention