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

Catalog Number 640HX0204

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2015

Event Type  malfunction  

Event Description

During coil embolization of an artery feeding a brain tumor, although the orbit galaxy (640hx0204/17046191) was delivered into the target lesion site, since the embolic coil did not properly loop properly to fill the target site, it was decided to recover the galaxy.However, while recovering the coil introducer, it became damaged 1cm from the distal end, and the galaxy could not be recovered for the re-use.Another galaxy of different size was used instead to continue the procedure, which was completed without further issues or delay.There were no patient injury/complications.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and the constant flush had been maintained at all times.No visible defect/damage was noted on the product prior to the event, and there was no embolic coil damage during the procedure.There was no unintended detachment of the coil observed in the vessel or in the mc.It was reported that the vessels were mildly tortuous, but not calcified.The complained product will be returned for analysis.No further information is available.

Manufacturer Narrative

The device was returned for analysis; however, the analysis has not yet been completed.Information regarding patient age, weight, medications, and concomitant devices were not provided.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Complaint conclusion: during coil embolization of an artery feeding a brain tumor, although the orbit galaxy (640hx0204/17046191) was delivered into the target lesion site, since the embolic coil did not properly loop to fill the target site, it was decided to recover the galaxy.However, while recovering the coil introducer, it became damaged 1cm from the distal end, and the galaxy could not be recovered for the re-use.Another galaxy of different size was used instead to continue the procedure, which was completed without further issues or delay.There were no patient injury/complications.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and the constant flush had been maintained at all times.No visible defect/damage was noted on the product prior to the event, and there was no embolic coil damage during the procedure.There was no unintended detachment of the coil observed in the vessel or in the microcatheter.It was reported that the vessels were mildly tortuous, but not calcified.The complaint product was returned for analysis.No further information is available.A non-sterile orbit galaxy helical xtrasoft coil was received coiled inside of a plastic bag.The hypotube was inspected and it was found without damage.The introducer was received un-zipped and it was found kinked.The support coil was received outside the introducer and it was found kinked.The gripper and embolic coil were received inside of introducer and without damages.The dispenser was received and no anomalies were noted in it.The support coil, gripper and embolic coil were inspected under microscope; the support coil was found kinked.The gripper and embolic coil were found without any damage.The functional test was performed.The orbit galaxy device could not be re-zipped due to the kink condition found on the introducer.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 positioning difficulty could not be evaluated due to the nature of the complaint.The re-sheathing difficulty and coil introducer damage was confirmed during product analysis.The failure experienced by the customer appears to be due to the kink condition found in the introducer; however, this and the damages found on the device could not be conclusively determined.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process.Additionally, inspections are in place that prevents these kinds of failures leaving from the manufacturing facility.Therefore, no corrective action will be taken at this time.

• Brand Name: XTRASOFT ORBIT GALAXY DETACHABLE COIL
• 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: 4567583
• MDR Text Key: 5473914
• Report Number: 3008264254-2015-00017
• 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,Followup
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 640HX0204
• Device Lot Number: 17046191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1