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

Catalog Number 640CF0515

Device Problems Migration or Expulsion of Device (1395); Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical devices: a 7fr sheath introducer by unknown manufacturer, chikai (asahi intecc, 0.014¿), a traxcess (terumo), a cerulean dd6 (medikit, 6fr), an excelsior xt-17 (stryker), an excelsior sl-10 (stryker), a scepter c (terumo), and a dcs syringe ii (lot unknown) were used for this procedure.The device was returned for analysis; however, the analysis has not yet been completed.(b)(4).Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during coil embolization of an anterior choroidal artery (acha) aneurysm, although the orbit galaxy ((b)(4)) was delivered into the target aneurysm and looped several times to fully place the embolic coil inside the aneurysm, before detaching the coil, a part of the coil migrated into the second aneurysm proximal to the acha aneurysm neck.The physician decided to repeat the embolization by double-catheter technique and attempted to recover the galaxy, but it was discovered that the embolic coil had become knotted inside the aneurysm, and could not be withdrawn back into the excelsior xt-17 microcatheter.Therefore, both the galaxy and microcatheter were withdrawn together from the patient.The procedure was successfully completed after two galaxy 4x10 coils that were implanted by double-catheter technique, and then more non-codman coils were added.There were no further issues.The event did not result in patient injury/complications or a clinically significant delay in the procedure.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 damages were noted on the product prior to the event.The complaint product was returned for analysis.No further information is available.

Manufacturer Narrative

Complaint conclusion: as reported by a healthcare professional, during coil embolization of an anterior choroidal artery (acha) aneurysm, although the orbit galaxy (640cf0515/17224082) was delivered into the target aneurysm and looped several times to fully place the embolic coil inside the aneurysm, before detaching the coil, a part of the coil migrated into the second aneurysm proximal to the acha aneurysm neck.The physician decided to repeat the embolization by double-catheter technique and attempted to recover the galaxy, but it was discovered that the embolic coil had become knotted inside the aneurysm and could not be withdrawn back into the excelsior xt-17 microcatheter.Therefore, both the galaxy and microcatheter were withdrawn together from the patient.The procedure was successfully completed after two galaxy 4x10 coils that were implanted by double-catheter technique, and then more non-codman coils were added.There were no further issues.The event did not result in patient injury/complications or a clinically significant delay in the procedure.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 damages were noted on the product prior to the event.No further information was available.A non-sterile orbit galaxy tdl cmplx fill coil 5x15 was received coiled inside of a plastic bag.The hypotube was inspected and no damages were noted on it.The introducer was received un-zipped separated of the unit and no damages were noted on it.The support coil, gripper and embolic coil were found outside of the introducer.The gripper and the embolic coil were inspected under microscope; the gripper was found without damage while the embolic col was found stretched/kinked and residues of dry blood can be observed on them.The od from the delivery tube was measured and was found within specification.The review of lot 17224082 revealed that 4 rejected units (oversized proximal bead) may be related to the reported complaint.However, the dhr review confirmed that the rejected units were properly segregated and discarded.Controls are in place to detect such nonconformities.No other issues were noted that were considered potentially related to the reported complaint.The events of coil migration and positioning difficulty could not be evaluated due to the nature of the events.The report of coil damage was confirmed.The cause of the stretched/kinked condition found on the embolic coil was apparently caused by applying excessive force on the device, but it could not be conclusively determined.However, this defect could not be related to the manufacturing process and procedural factors appear to have contributed to have this damage.Inspections are in place that prevents this kind of failure from leaving the manufacturing facility.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process.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 dr; raynham MA
• Manufacturer Contact: kimberly soter ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 5088288310
• MDR Report Key: 5331704
• MDR Text Key: 34588215
• Report Number: 3008264254-2015-00081
• 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
• Type of Report: Initial,Followup
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 640CF0515
• Device Lot Number: 17224082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1