MAUDE Adverse Event Report: COVIDIEN PIPELINE EMBOLIZATION DEVICE; FLOW DIVERSION

Model Number FA-77500-18

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/03/2014

Event Type  malfunction  

Event Description

It was reported that during an embolization procedure the device would not release from the capture coil.It was further reported that when the physician went to trap the pipeline braid between the capture coil and the catheter the delivery wire broke off.The wire was successfully removed from the patient without the use of snare or alligator.The pipeline remains implanted.There were no patient complications reported as a result of this event.

Manufacturer Narrative

The device will not be returned for evaluation as it was implanted in the patient.All segments of the wire were removed and discarded along with the pushwire.The lot history record of the reported lot number has been reviewed and no issues were noted that would have contributed to this event.(b)(4).

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: FLOW DIVERSION
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 4294362
• MDR Text Key: 21722097
• Report Number: 2029214-2014-00694
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2015
• Device Model Number: FA-77500-18
• Device Lot Number: 9971070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2014
• Initial Date FDA Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2014
• 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 Age: 74 YR
• Patient Weight: 101