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

Model Number 405154

Device Problems Difficult to Insert (1316); Material Too Rigid or Stiff (1544)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2023

Event Type  Injury  

Event Description

During the implant procedure, it was noted that the guidewire included in the package was too hard and stiff to straighten the j end of the guidewire resulting in the guidewire being difficult to insert into the cephalic vein.An additional puncture site in the subclavian vein was done as a way of access with the same sheath and guidewire with no adverse patient consequences.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported guidewire insertion difficulty and guidewire too stiff issue remains unknown.

• Brand Name: PEEL-AWAY INTRODUCER, 7F TW, DI-LOCK, 14CM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17920898
• MDR Text Key: 325500994
• Report Number: 3005334138-2023-00464
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05415067041210
• UDI-Public: 05415067041210
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 405154
• Device Lot Number: 8842880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• 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