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

Model Number UNK-CV-SR-SENTRANT

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

Patient Problems Unspecified Infection (1930); Local Reaction (2035)

Event Type  Injury  

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 cardiovascular surgeon in practice 20 years, who has used the device 200 times in total of which all of those times were in the last 12 months.During use of the sentrant, the following complications were encountered in the last 12 months; allergic response to materials (20 occasions) <(>&<)> infection (on 20 occasions) half of these allergic response and infection events were assessed by the physician to be related to the device.The physician assessed the infection and the allergic response to materials events, as very concerning,somewhat concerning and not at all concerning.The physician did not know that the allergic response to materials was a potential complication with use of the sentrant but did known infection was a potential issue as noted in the ifu of the device.The physician had the opinion that the sentrant performed as expected when it was used.No further information has or will be provided.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Type of Device: INTRODUCER, 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 Key: 11855384
• MDR Text Key: 251689881
• Report Number: 9612164-2021-01998
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-CV-SR-SENTRANT
• Device Catalogue Number: UNK-CV-SR-SENTRANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2021
• 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): Other