MAUDE Adverse Event Report: ST. JUDE MEDICAL PEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 10.5F; INTRODUCER, CATHETER

Model Number	405122
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.The results of the investigation revealed the introducer, batch number 5507376 expired on 30apr2019 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.Based on the information received, the cause of the reported insertion difficulties remains unknown.The use of expired product is consistent with user error.
Event or Problem Description
This report is to advise of an event observed during analysis confirming the introducer was used beyond its shelf life.

• Brand Name: PEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 10.5F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9103432
• Report Number: 3005334138-2019-00533
• Device Sequence Number: 2358334
• Product Code: DYB
• UDI-Device Identifier: 05414734204224
• UDI-Public: 05414734204224
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 09/23/2019

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: 04/30/2019
• Device Model Number: 405122
• Device Lot Number: 5507376
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR