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

Model Number	SENSH1428W
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the sentrant sheath returned with the dilator locked in the luer.The dilator was unlocked and retracted.The ring and seal were removed on the dilator.Inspection of the ring tabs confirmed an indentation on tab 1.The tab appeared to have been orientated incorrectly in the window.There was no damage observed to the second tab.The reported detachment was confirmed through analysis.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A sentrant sheath was intended to be used in the endovascular treatment of a patient.It was reported that during the index procedure the sheath was advanced but the dilator was attempted to be removed , the hemostatic valve came with it.This sheath was then removed and replaced with a new sentrant sheath of the same lot number without any issues encountered.As per the physician the cause of the event is the hemostatic valve not being connected to the rest of the sheath.No additional clinical sequalae were proved and the patient is fine.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• MDR Report Key: 9563315
• Report Number: 9612164-2020-00137
• Device Sequence Number: 3230017
• Product Code: DYB
• UDI-Device Identifier: 00643169792586
• UDI-Public: 00643169792586
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K123990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2021
• Device Model Number: SENSH1428W
• Device Catalogue Number: SENSH1428W
• Device Lot Number: 00144225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 78