MAUDE Adverse Event Report: COVIDIEN (IRVINE) REBAR IR; CATHETER, CONTINUOUS FLUSH

Model Number 105-5083-153

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2015

Event Type  malfunction  

Event Description

The following report was received through medtronic (covidien): the physician was unable to see the marker band at any point on the distal end of the catheter under fluoroscopy.It was very difficult to advance or push the device forward due to the lack of the distal marker band and avoiding any risk for the patient.Still the procedure was finalized successfully and the patient was fine.The device was discarded.

Manufacturer Narrative

The device will not be returned for evaluation as it was discarded; therefore, the event cause could not be determined.The lot history record review of the reported lot number showed no discrepancies that would have contributed to the reported experience.(b)(4).

• Brand Name: REBAR IR
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine ; 9496801224
• MDR Report Key: 4965749
• MDR Text Key: 6193294
• Report Number: 2029214-2015-00855
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2017
• Device Model Number: 105-5083-153
• Device Lot Number: A040497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2015
• 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