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

Model Number QC-2-4-HELIX

Device Problems Device Damaged Prior to Use (2284); Separation Failure (2547); Physical Resistance (2578)

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

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Attempts have been made to obtain additional information, however our attempts have been unsuccessful.

Event Description

Medtronic received report that "the coil was not coming out of hypotube." the device was flushed and re-attempted to be pushed out.The aneurysm was ruptures, saccular shape and in the pcom.The aneurysm diameters are 3mm max and 1.8mm neck.The blood flow and the anatomy were normal.

Manufacturer Narrative

The coil was returned for evaluation.The coil was found to be still within the dispenser track and inside of the opened inner pouch.No bend was found on the pushwire.The implant coil appeared to be damaged and stretched within the introducer sheath.The implant coil could not be pushed out from within the introducer sheath for further evaluation, as it was found to be stuck.The outer diameter (od) of the implant coil tip was measured and found to be within specification.All other subassemblies appeared to be normal and no other anomalies were observed.Based on the device analysis and the reported event details, the report of coil resistance/stuck in sheath was confirmed.The implant coil was found to be damaged and stretched and it could not be pushed out from the introducer sheath.However, the cause for the damages could not be determined.Although the customer reported the coil was flushed prior to the event, the customer reported that they did not hydrate the coil per the instructions or use (ifu) prior to the event.It is possible that the implant coil became damaged during flushing of the coil.It is likely the damages to the implant coil led to the difficulty pushing the implant coil out from the introducer sheath during testing.Per our instructions for use (ifu): slowly and simultaneously remove the detachable coil and introducer sheath from the dispenser track.Inspect proximal implant delivery pusher for irregularities.If irregularities exist, replace with a new detachable coil.Slowly advance the detachable coil out of the introducer sheath into the palm of your gloved hand and inspect for irregularities of the coil or the detachment zone.Due to potential risks of irregularities, a visual proof should be performed.If irregularities exist, replace with a new detachable coil.Gently immerse the detachable coil and its detachment zone in heparinized saline.Take care not to stretch the coil during this procedure, in order to preserve the coil memory.While still immersed in the heparinized saline, point introducer sheath vertically into saline and gently retract the distal tip of the coil into the introducer sheath.All products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Code changed and the device was not able to be pushed out the protective sheath.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report the coil experienced resistance and could not be pushed out of the "hypotube¿ protective sheath.The patient was treated with a new coil.No patient injury occurred.

Manufacturer Narrative

This report was submitted with the date of report as the manufacture notified date.A correction is being filed to reflect the date of report as the date the initial report was submitted.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BARE 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: 6872499
• MDR Text Key: 87316559
• Report Number: 2029214-2017-01060
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K081465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2018
• Device Model Number: QC-2-4-HELIX
• Device Catalogue Number: QC-2-4-HELIX
• Device Lot Number: A135090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2015
• 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
• Patient Age: 45 YR