MAUDE Adverse Event Report: COVIDIEN (IRVINE) AXIUM HELIX; DEVICE, EMBOLIZATION, VASCULAR

Model Number QC-2-2-HELIX

Device Problem Device Damaged by Another Device (2915)

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

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that during a left posterior communicating artery aneurysm coiling procedure, the coil was reported to have perforated the catheter at about 20cm into the proximal segment.The microcatheter was replaced and the coil was implanted with a replacement microcatheter.No patient injury was reported.

Manufacturer Narrative

The device was not returned for analysis, as it was reported to have been implanted in the patient.Since the device was not returned our investigation was limited and a definitive conclusion could not identified.Mdr related to this event: 2029214-2016-01104, 2029214-2016-01114.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIUM HELIX
• Type of Device: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 6174358
• MDR Text Key: 62379049
• Report Number: 2029214-2016-01114
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2019
• Device Model Number: QC-2-2-HELIX
• Device Lot Number: A262497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR