MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	641CX0306
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial/final mdr is the only report being submitted for mfr report #2954740-2017-00109.Procode: krd/hcg.(b)(4).Concomitant medical products: echelon 10, medtronic product, galaxy g2 coil 2.5x3.5.Conclusion: concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned by the end user/hospital before being returned, which may have produced further damage.It is also unknown if the device was improperly handled for returned packaging or was further manipulated and/or inspected post-procedurally.In addition, any trace or other evidence that may have been complaint related may have been altered or removed prior to being returned due to post-procedural handling, cleaning, and packaging.An unreported severe kink was found on the dpu located 61.0 centimeters off the proximal end.Unreported coil detachment was also noted and the coil was not returned.The coil detachment was mechanical in nature.No manufacturing defects were found.The circumstances of how and when all the unreported damage occurred cannot be determined.The complaint of the coil being impeded and stretched is not confirmed.Without the return of the detached coil and the echelon 10 microcatheter used in the procedure, the root cause of the coil being impeded and stretched cannot be determined; however, the most likely contributing factor may have been due to distal interference of an unknown source and location inside the microcatheter.This interference may have also caused the coil to become temporarily anchored which caused the coil to stretch upon removal.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.
Event or Problem Description
It was reported by a healthcare professional that a g2 cmplx xs coil (641cx0306/p11684) got stuck in the mid portion of the microcatheter (echelon 10, medtronic product) and found to be stretched when it was removed from the microcatheter during an ica terminus aneurysm coiling procedure.The coil was still attached to the delivery system when it was removed from the patient.Reportedly, a galaxy g2 coil 2.5x3.5 was successfully used with the microcatheter prior to this event.Only the g2 cmplx xs coil (complaint product) was removed from the patient.The procedure was delayed about 10 minutes and was completed with other coils.The patient¿s status post procedure was well.The patient was a (b)(6) male; the aneurysm was 2.8 wide, 2.2 long, with a 1.6 neck.There were no patient complications as a result of this event, nor was any additional intervention required.An adequate continuous flush was maintained through the catheter.The device is being returned for evaluation.

• Brand Name: ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6573307
• Report Number: 2954740-2017-00109
• Device Sequence Number: 91749
• Product Code: KRD
• UDI-Device Identifier: 10878528008948
• UDI-Public: (01)10878528008948(17)201231(10)P11684
• Combination Product (Y/N): N
• PMA/510(K) Number: K120686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 641CX0306
• Device Lot Number: P11684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2017
• Initial Report FDA Received Date: 05/17/2017
• Patient Sequence Number: 1
• Patient Age: 45 YR