MAUDE Adverse Event Report: ST. JUDE MEDICAL PEEL-AWAY INTRODUCER, 7F TW, DI-LOCK, 14CM; INTRODUCER, CATHETER

Model Number	405154
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation confirmed that peel-away introducer expired on 31may2019, which was prior to the reported event date of (b)(6) 2019.A review of distribution records confirmed that this product was distributed prior to its expiration date.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, including verification of the expiration date listed on the product label.The cause of the use of expired product is consistent with user error.The ifu states to check the "use by" date before using the product.
Event or Problem Description
An expired introducer was opened and used for an ablation procedure.There were no adverse consequences to the patient.
Event or Problem Description
In (b)(6) 2018 the user facility placed a single unopened device with a use-by date of 31 may 2019 back into the incorrect outer box, which reflected a use-by date of september 2019.This sheath was returned to the manufacturer and later was sent out to another user.The device was used in the procedure on (b)(6) 2019 and later determined to have been used after the expiration date.No adverse consequences to the patient have been reported.

• Brand Name: PEEL-AWAY INTRODUCER, 7F TW, DI-LOCK, 14CM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8777720
• Report Number: 3005334138-2019-00364
• Device Sequence Number: 11397994
• Product Code: DYB
• UDI-Device Identifier: 05414734204415
• UDI-Public: 05414734204415
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K791129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019

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: 05/31/2019
• Device Model Number: 405154
• Device Catalogue Number: 405154
• Device Lot Number: 5539017
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 07/24/2019
• 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
• Patient Age: 86 YR