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

Model Number UNK-CV-SR-SENTRANT

Device Problems Fluid/Blood 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.

• 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: 11847232
• MDR Text Key: 251422925
• Report Number: 9612164-2021-01951
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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