MAUDE Adverse Event Report: ST. JUDE MEDICAL PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 8F; INTRODUCER, CATHETER

Model Number 405112

Device Problems Entrapment of Device (1212); Difficult to Insert (1316)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 10/13/2021

Event Type  Injury  

Event Description

During a percutaneous venipuncture, the guidewire became lodged in the needle and the device was removed from the patient.Jugular vein trauma occurred and a new puncture was required and the procedure was stopped.

Manufacturer Narrative

Additional information: d9, g3, h2, h3 one 8.5f peel-away introducer needle and guidewire assembly were received for evaluation.The device was returned due to the guidewire stuck inside the needle.The guidewire was removed and foreign material was found at the location the guidewire was stuck in the needle.Additional testing revealed the returned foreign material appeared to match biological material.The guidewire outside diameter and the needle inside diameter measurement were consistent with manufacturing specifications.The returned guidewire was able to be fully inserted through returned needle after fm removal; however, resistance was noted consistent with the location of the guidewire damage.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the guidewire being lodged inside the needle and subsequent biological material on the guidewire could not be conclusively determined.

• Brand Name: PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 8F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL (AFD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12794104
• MDR Text Key: 280949845
• Report Number: 3005334138-2021-00689
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734204125
• UDI-Public: 05414734204125
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K894431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 405112
• Device Catalogue Number: 405112
• Device Lot Number: 7341975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 02/09/2022
• Supplement Dates FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other