MAUDE Adverse Event Report: ST. JUDE MEDICAL PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 7F; PERMANENT LEAD INTRODUCER/WIRE, GUIDE, CATHETER

Model Number	405108
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a pacemaker implantation procedure, it was noted that the guide wire did not progress inside the introducer lumen.The introducer was exchanged and a new puncture in the subclavian vein was necessary.The procedure was then successfully completed with no adverse patient consequences.
Additional 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 insertion difficulty could not be conclusively determined.
Additional Manufacturer Narrative
One 7f peel-away introducer dilator was returned for evaluation.The results of the investigation revealed the guidewire could not be fully inserted through the returned dilator.Further investigation revealed the dilator tube was occluded by excess dilator tubing material.The manufacturer will continue to monitor its complaint database for purposes of tracking and monitoring similar events for significant trend occurrence.

• Brand Name: PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 7F
• Common Device Name: PERMANENT LEAD INTRODUCER/WIRE, GUIDE, 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: 17629119
• Report Number: 3005334138-2023-00378
• Device Sequence Number: 20744431
• Product Code: DYB
• UDI-Device Identifier: 05415067040879
• UDI-Public: 05415067040879
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K894431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 405108
• Device Lot Number: 8654704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 10/26/2023; 12/21/2023
• Initial Report FDA Received Date: 08/27/2023
• Supplement Report FDA Received Date: 10/30/2023; 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown