MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/10/2017

Event Type  Injury  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer states that on (b)(6) 2017 they first used a cordis aquatrack hydrophilic nitinol guide wire without success.The customer then used a palindrome chronic catheter kit, 83 cm guide wire and attempted to place a right internal jugular line.After several attempts the wire would not pass.Following surgery as part of follow-up for failed placement, a chest x-ray was taken and it was discovered that a piece of guide wire was retained in the right neck area of the patient.The two guide wires (one cordis, the other covidien) had already been discarded and the operating room suite cleaned so it is unknown which of the guide wires broke in the patient.The patient was sent to another hospital where the wire was removed without further incident.On follow-up, the hospital was not able to identify which wire had been removed from the patient and the removed wire had already been discarded.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: diane matheus ; 15 hampshire street; mansfield, MA 02048 ; 5085421480
• MDR Report Key: 6940667
• MDR Text Key: 89223565
• Report Number: 3009211636-2017-05318
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 235522X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention