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

Model Number	SENSH2228W
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The main component of the system.Other relevant device(s) are: sensh2628w, sn: (b)(4), expiration date: 2018-02-16, udi # (b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A sentrant sheath was selected and used for the endovascular treatment in a patient.It was reported that the outer box label indicated that this was a sentrant 22 fr sheath.However, the inner pouch package indicates it is a sentrant 26fr sheath.The actual sheath was a sentrant 22 fr.The sentrant 22 fr sheath was successfully used in the patient, as the discrepancy in the labeling was discovered during the inventory for billing to the patient¿s chart after the sentrant sheath was used.Per the physician, the cause of the event is related to the device labeling.No clinical sequelae were reported and the patient is fine.
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 CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• MDR Report Key: 6619804
• Report Number: 2953200-2017-00938
• Device Sequence Number: 13638100
• Product Code: DYB
• UDI-Device Identifier: 00643169150355
• UDI-Public: 00643169150355
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 05/13/2017

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: 02/16/2018
• Device Model Number: SENSH2228W
• Device Catalogue Number: SENSH2228W
• Device Lot Number: 00120820
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2017
• Supplement Date Received by Manufacturer: 05/13/2017
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR