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

Model Number SENSH2028W

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

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 01/15/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

A sentrant sheath was used in the endovascular treatment of a patient.It was reported that after successful heart valve implantation, there was massive femoral haemorrhage after removal of the 20 fr sentrant sheath.The physician was unable to control the bleeding by direct manual pressure application and the patient died.As per the physician the cause of the event was related to the patients obesity.It was noted that the bleeding was not associated with any mdt products used in the procedure.No additional clinical sequelae were reported.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 8273941
• MDR Text Key: 133971635
• Report Number: 2953200-2019-00155
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/14/2019
• Device Model Number: SENSH2028W
• Device Catalogue Number: SENSH2028W
• Device Lot Number: 00134323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2019
• Date Device Manufactured: 09/14/2018
• 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
• Patient Age: 68 YR
• Patient Weight: 120