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

Catalog Number 640CF0510

Device Problems Difficult To Position (1467); Stretched (1601); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2015

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for analysis; however, the analysis has not yet been completed.Information regarding patient demographics were not available.Additional information will be submitted within 30 days of receipt.

Event Description

During coil embolization of an unruptured anterior communicating artery aneurysm, the physician implanted the orbit galaxy ((b)(4)) coil to frame the target site: however, it protruded into the neck.Therefore, he withdrew the coil, but the zipper of the introducer sheath was stuck and it could not be re-sheathed.The coil was replaced with another coil, and the procedure was successfully completed without a further issue.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.No visible damage was noted on the product prior to the event.Excessive force had not been used on the device, and there had been no resistance within the microcatheter.There were no patient injury/complications and no clinically significant delay in the procedure.No further information is available.

Manufacturer Narrative

(b)(4).Complaint conclusion: during coil embolization of an unruptured anterior communicating artery aneurysm, the physician implanted the orbit galaxy (640cf0510/ 17025652) coil to frame the target site: however, it protruded into the neck.Therefore, he withdrew the coil, but the zipper of the introducer sheath was stuck and it could not be re-sheathed.The coil was replaced with another coil, and the procedure was successfully completed without a further issue.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.No visible damage was noted on the product prior to the event.Excessive force had not been used on the device, and there had been no resistance within the microcatheter.There were no patient injury/complications, and no clinically significant delay in the procedure.No further information was available.A non-sterile orbit galaxy tdl complex fill coil was received coiled inside of a plastic bag.The hypotube was inspected and it was found kinked.The introducer was found zipped without damage.Part of the support coil was found outside of the introducer from the proximal end; the rest of it the gripper and the embolic coil were found inside of the introducer.The gripper and embolic coil were inspected under microscope through of the introducer; no damages were noted on the gripper just residues of dry blood can be observed on it while the embolic coil was found stretched.The introducer was found zipped and it can be un-zipped and re-zipped even with the part of the support coil outside of the introducer from the proximal end.A review of the manufacturing documentation associated with this lot 17025652 presented no issues during the manufacturing process that can be related to the reported complaint.The coil positioning difficulty could not be confirmed due to the nature of the event; however the failure experienced by the customer appears to be related to the stretched condition found on the embolic coil and the kinks found on the hypotube.The damages found on the device were apparently caused by applying excessive force on it, but it could not be conclusively determined.The re-zipping difficulty was not confirmed since the introducer was found zipped and it could be unzipping and re-zipping.The customer most likely experienced resheathing difficulty due to part of the support coil was found herniated outside of the introducer from the proximal end.Inspections are in place that prevents this kind of failure from leaving the manufacturing facility.Since there was no evidence of a manufacturing issue related to the event, 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 dr; raynham MA
• Manufacturer Contact: kimberly soter ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 5088288310
• MDR Report Key: 5061853
• MDR Text Key: 26031257
• Report Number: 3008264254-2015-00063
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 640CF0510
• Device Lot Number: 17025652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1