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

Model Number	SENSH2028W
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	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A sentrant sheath was used as a conduit for an unknown device during an unknown procedure.It was reported during the index procedure the valve on the sentrant sheath became loose and needed to be popped back into place.The valve was popped back into place and the case continued with no impact to the patient reported.Per the physician the cause of the event was suspected to be fault with the device.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information: there was no issue with the valve of the sentrant noted during initial prep of the device.It was noticed when the dilator was removed from the sheath after it was inserted into the body.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.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• MDR Report Key: 9165548
• Report Number: 9612164-2019-04266
• Device Sequence Number: 13994449
• Product Code: DYB
• UDI-Device Identifier: 00643169792616
• UDI-Public: 00643169792616
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 12/05/2019

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: 06/20/2021
• Device Model Number: SENSH2028W
• Device Catalogue Number: SENSH2028W
• Device Lot Number: 00142561
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 10/08/2019; 11/15/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 10/31/2019; 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 109