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

Catalog Number 640CF3509

Device Problems Difficult To Position (1467); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2014

Event Type  malfunction  

Event Description

During coil embolization of an aneurysm at the patient¿s middle cerebral artery-m1 segment the orbit galaxy coil (640cf3509/15726863) protruded out of the aneurysm and the coil could not be resheathed.The artery was moderately tortuous but not calcified.The patient was a (b)(6) female of unknown weight.It was reported that a flexor shuttle guiding sheath 6fr (cook inc., type unknown), a radifocus gt guidewire 035 (terumo, type unknown), a chikai 14 (asashi intecc, type unknown), a fubuki catheter 4.2fr.(asahi intecc, type unknown), an excelsior sl-10 microcatheter(type unknown), and a dcs syringe ii (lot unknown) were also used for the above procedure.No details of the other accompanying devices are available.The above procedure was approached from the right femoral artery.During the surgery, the physician was once able to position the reported coil into the aneurysm.But then the coil protruded out 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.The coil was replaced with another galaxy (640cf0308, lot unknown), and the physician was able to place the coil without re-sheathing.The procedure was successfully completed without further issues or delay.There was also no patient injury/complications reported.

Manufacturer Narrative

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.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 was observed in the vessel or in the microcatheter.The product will be returned for evaluation.No further information is available.Concomitant products: flexor shuttle guiding sheath 6fr (cook inc., type unknown); radifocus gt guidewire 035 (terumo, type unknown); chikai 14 (asashi intecc, type unknown); fubuki catheter4.2fr.(asahi intecc, type unknown); excelsior sl-10 microcatheter(type unknown); orbit galaxy (640cf0308, lot unknown).Review of dhr for lot 15726863 concluded that no issues were noted that were considered potentially related to the reported complaint.

Manufacturer Narrative

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.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 was observed in the vessel or in the microcatheter.The product will be returned for evaluation.No further information is available.A non-sterile orbit galaxy complex fill coil 3 x 9 was received 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, gripper and embolic coil were received outside of introducer.The support coil was inspected and it was found kinked, the gripper was inspected and was found without any damage while the embolic coil was found kinked.The introducer, gripper and embolic coil were inspected under microscope; the introducer was found kinked, the gripper was found without damage while the embolic coil was found kinked.The orbit galaxy device was attempted to be re-zipped, but it 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 failure experienced by the customer that the coil protruded into the aneurysm could not be evaluated.The failure reported by the customer that the coil could not be resheathed was confirmed in functional 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 as per that prevent this kind of failure from leaving from the 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: 4110588
• MDR Text Key: 16184366
• Report Number: 1226348-2014-30074
• 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,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2014

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: 09/30/2014
• Device Catalogue Number: 640CF3509
• Device Lot Number: 15726863
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2014
• Initial Date FDA Received: 09/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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: 54 YR