MAUDE Adverse Event Report: COOK, INC. COOK MEDICAL MICROPUNCTURE INTRUDUCER SET; INTRODUCER, CATHETER

Model Number MPIS-401-NT-U-SST

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Chest Pain (1776); Neck Pain (2433); Device Embedded In Tissue or Plaque (3165)

Event Date 11/07/2022

Event Type  Injury  

Event Description

Patient experienced right upper chest and neck pain following an ep ablation procedure were an ij access device was also placed.Several days later the patient was directed to the emergency department per the provider to investigate the pain.A ct exam discovered an extra luminal linear metallic object within the soft tissues of the base of the neck and extending into the right mediastinal region.It had the appearance of a fractured wire.Extraction was scheduled and completed to remove the metal fragment on (b)(6) 2022 at a different area hospital.The product used for the ij placement that was deemed to be the metallic object is cook item mfg# g47944, lot 15025746.Notified (b)(4) with cook of the event and product that broke during use.Fda safety report id # (b)(4).

• Brand Name: COOK MEDICAL MICROPUNCTURE INTRUDUCER SET
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK, INC.; bloomington IN 47402 4195
• MDR Report Key: 15834477
• MDR Text Key: 304114971
• Report Number: MW5113391
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/16/2022

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
• Device Operator: Health Professional
• Device Model Number: MPIS-401-NT-U-SST
• Device Catalogue Number: G47944
• Device Lot Number: 15025746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 87 KG