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

Model Number	SENSH2028W
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Liver Laceration(s) (1955); Cardiac Tamponade (2226); Obstruction/Occlusion (2422)
Date of Event	02/09/2022
Type of Reportable Event	Death
Event or Problem Description
Two sentrant sheaths were used as a conduit during a medtronic valve implant.It was reported during the index procedure that the patient had multiple complications during the procedure.When the delivery system was removed, right femoral occlusion was observed.After closure with percoles, without lacerations or bleeding, a covered stent was implanted with excellent results.The patient was stable at the end of the procedure.It was reported that in the icu, after 2 hours after leaving the room with, the patient developed hypotension and was diagnosed with cardiac tamponade.An urgent pericardiocentesis was performed, and another bleed was identified in the puncture attempt.The patient was referred to the operating room, where a sternotomy and exploratory laparotomy were performed.Multiple lacerations were identified in the liver as the cause of the bleeding.On the day after the index procedure, the patient progressed to death.Per physician, the cause of death was due to hemorrhagic shock.No additional clinical sequelae was reported and the patient expired.
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: sensh1628w, serial/lot #: (b)(4), ubd: 24-may-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Common Device Name: 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: 13706645
• Report Number: 9612164-2022-00922
• Device Sequence Number: 20400187
• Product Code: DYB
• UDI-Device Identifier: 00643169792616
• UDI-Public: 00643169792616
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K123990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: SENSH2028W
• Device Catalogue Number: SENSH2028W
• Device Lot Number: 00157734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 03/09/2022
• Date Device Manufactured: 04/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 65 KG