MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ORBIT GALAXY DETACHABLE COIL SYSTEM; ARTIFICIAL EMBOLIZATION DEVICE

Catalog Number 640CF0202

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2015

Event Type  malfunction  

Event Description

During a stent assisted coil embolization procedure of the internal carotid artery, a 2x2 orbit galaxy coil (640cf0202/ 17142142) pushed the stryker sl-10 microcatheter out of the aneurysm when the coil was being advanced, and during resheathing of the coil, there was zipping difficulty.The coil was being introduced into the aneurysm when the microcatheter lost access to the aneurysm.The coil was removed to regain access with the wire; however, there was a problem with re-zipping the coil once it was removed.There had been no problem with introducing the coil through the microcatheter, and no damage to the microcatheter.All devices were used and prepped as per the ifu.There was no problem during unsheathing the coil, and excessive force had not been used.All other coils used in the procedure worked fine.There was no clinically significant delay in the procedure.There was no damage to the actual coil.The patient was doing fine and was discharged the next morning.

Manufacturer Narrative

Information regarding patient age, gender and weight were not provided.Complaint conclusion: the device was returned for analysis.A non-sterile orbit galaxy complex fill coil 2x2 was received coiled inside of a plastic bag.The hypo-tube was inspected and no damages were noted on it.The introducer was found unzipped, and it was found kinked.No damages were noted on the support coil.The gripper and embolic coil were found outside of the introducer.The introducer, gripper and the embolic coil were inspected under microscope; the introducer was found kinked, the gripper was found without damage while the embolic coil was found stretched.The introducer could not be re-zipping due to the kinked condition.A review of the manufacturing documentation associated with this lot 17142142 presented no issues during the manufacturing process that can be related to the reported complaint.The difficulty positioning the coil that resulted in the microcatheter losing target position could not be evaluated.The re-zipping difficulty was confirmed.This appears to be related to the kinked condition found on the introducer, which was apparently caused by applying excessive force on it but it could not be conclusively determined.Since it was reported that there was no damage to the actual coil, the coil stretching was most likely related to post-procedural handling/shipping of the coil that was outside of the introducer.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process and procedural factors appear to have contributed to have this failure.Additionally inspections are in place that prevents these kinds of failures from leaving from the manufacturing facility.Therefore no corrective action will be taken at this time.This is an initial/final mdr.

• Brand Name: ORBIT GALAXY DETACHABLE COIL SYSTEM
• Type of Device: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: duane durbin ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 5088288310
• MDR Report Key: 4826262
• MDR Text Key: 5843262
• Report Number: 3008264254-2015-00034
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/15/2015

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: 10/31/2016
• Device Catalogue Number: 640CF0202
• Device Lot Number: 17142142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2015
• Initial Date FDA Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STRYKER SL-10 MICROCATHETER