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

Model Number	SENSH1628W
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A sentrant introducer sheath was attempted to be used as an accessory device for a unknown procedure.It was reported that during the index procedure, the sheath was removed from the right common femoral artery access and the sutures were cinched down.It was stated that significant bleeding was still present and the third proglide device was attempted to prevent the bleeding from resulting in a cut down.It was reported that the physician was unable to achieve adequate hemostasis and thus a surgical cutdown was performed with primary repair of the vessel and multiple layers of running sutures.Investigator assessed the event as possibly related to the sheath, not related to the study procedure and not related to the transcatheter aortic valve.Sponsor assessed the event as related to the sheath, related to the study procedure, but not related to the transcatheter aortic valve.As per the physician the cause was likely the recent use of angioseal for diagnostic cath at outside hospital which did not allow for perclose sutures to seal.No additional clinical sequalae were provided and the patient is recovered.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie ; EI
• MDR Report Key: 12391681
• Report Number: 9612164-2021-03357
• Device Sequence Number: 4648864
• Product Code: DYB
• UDI-Device Identifier: 00643169792593
• UDI-Public: 00643169792593
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2021

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: 04/07/2023
• Device Model Number: SENSH1628W
• Device Catalogue Number: SENSH1628W
• Device Lot Number: 00157732
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 94