MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE CATHETERS.CAREFLOW¿; CATHETER, INTRAVASCULAR, THERAPEUTIC

Device Problem Difficult to Remove (1528)

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

Event Date 02/01/2001

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned at a later date, the investigation will be re-opened.

Event Description

A clinical literature search was completed for a central venous line medical device.The study alleges that an introducer guidewire could not be removed following insertion and catheter placement.The guidewire was found to have passed through the anterior wall of the "patients" internal jugular vein and had coiled up within the sternocleidomastoid muscle and subcutaneous tissue within the extravascular space.Surgical removal of the guidewire was necessary.No additional patient consequences to report.

• Brand Name: CATHETERS.CAREFLOW¿
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE; 198 yishun ave 7; singapore, 76892 6; SN 768926
• Manufacturer (Section G): MERIT MEDICAL SINGAPORE; 198 yishun ave 7; singapore, 76892 6; SN 768926
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 15685573
• MDR Text Key: 302568969
• Report Number: 8020616-2022-00105
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00884450322192
• UDI-Public: 884450322192
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/05/2022

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention