MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, LAMP¿ 90, 63 CM LENGTH, 8.5F; INTRODUCER, CATHETER

Model Number	407358
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The report was submitted inadvertently as this event occurred during preparation.
Additional Manufacturer Narrative
One 8.5f swartz braided introducer sheath and dilator were received for evaluation.Resistance was noted near the distal end of the dilator when a brk needle/stylet assembly from current inventory was advanced through the returned dilator and sheath.The dilator tubing was cut lengthwise and evidence of skiving was noted along the inner wall of the dilator.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, the cause of the skiving remains unknown.
Event or Problem Description
This event is being reported based on analysis revealing skiving of the dilator.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, LAMP¿ 90, 63 CM LENGTH, 8.5F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9710939
• Report Number: 3005334138-2020-00058
• Device Sequence Number: 19746539
• Product Code: DYB
• UDI-Device Identifier: 05414734205535
• UDI-Public: 05414734205535
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K052644
• 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): 02/14/2020

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: 08/31/2022
• Device Model Number: 407358
• Device Catalogue Number: 407358
• Device Lot Number: 7193353
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1