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

Catalog Number 640CF0308

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2014

Event Type  malfunction  

Event Description

During the coil embolization of a right vertebral artery, the physician was able to position the orbit galaxy (640cf0308/16051014) coil into the target aneurysm; however, the coil migrated from the aneurysm, and the physician decided to recover the coil.The physician carefully slid the zipper, however the zipper was stuck and the coil could not be re-sheathed further.Since the size of the complaint coil also did not match with the aneurysm, the coil was replaced with a different product, and the procedure was successfully completed without further issue or delay.There was also no patient injury/complications reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu, and the constant flush had been maintained at all times through the excelsior sl-10 microcatheter.Prior to use, no defect (kink, bends, etc.) was noted on the product by visual inspection.Also no damages were reported on the other devices after the event.No unintended detachment of the complaint coil was observed in the vessel or in the microcatheter.The complaint product will be returned for evaluation.No further information is available.

Manufacturer Narrative

(b)(6).Complaint conclusion: the device was returned for analysis.A non-sterile orbit galaxy complex fill coil 3 x 8 was received coiled inside of a plastic bag.The hypotube was inspected and it was found kinked.The introducer was received unzipped and it was found elongated.The support coil, gripper and embolic coil were received outside of the introducer, the support coil and gripper were found without damage, just residues of dry blood can be observed on the gripper while the embolic coil was found stretched/kinked.The introducer, gripper and embolic coil were inspected under microscope; the introducer was found elongated, the gripper shows residues of dry blood on it and the embolic coil was found stretched/kinked.Due to the elongated condition of the introducer cannot be re-zipping.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The coil herniation out of the aneurysm could not be evaluated without procedural films due to the nature of the complaint.The root cause of the coil herniation could not be determined; however, procedural factors or the coil not being the correct size for the aneurysm may have contributed to the event.Since it was reported that there was no damage noted to the device after the procedure, and stretched coil would be easily noticed, this damage most likely occurred during post-procedure handling/shipping.The re-zipping difficulty was confirmed through product analysis and appears to be due to the elongated condition found on the introducer.The damages found on the introducer were apparently caused by applying excessive force, but this could not be conclusively determined.However these defects could not be related to the manufacturing process and procedural factors appear to have contributed to have these damages.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process.Additionally, inspections are in place to prevent these kind of failures from leaving from the manufacturing facility.Therefore no corrective action will be taken at this time.

• Brand Name: ORBIT GALAXY DETACHABLE COIL SYSTEM
• Type of Device: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4112392
• MDR Text Key: 21805621
• Report Number: 1226348-2014-30075
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/08/2014

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: 12/31/2015
• Device Catalogue Number: 640CF0308
• Device Lot Number: 16051014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2014
• Initial Date FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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: 45 YR