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

Catalog Number	641CX2535
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of one initial/final mdr being submitted for this complaint 2954740-2016-00212.It is unknown which galaxy coil (lot# p10635, c11960, p11693) failed to detach.Manufacturing date, expiration date and udi for the other two lots are as follows.Catalog# 641cf0306, lot# p10635, manf date:10-jun-2015, exp date: 31-may-2020, (b)(4).Catalog# 641hx0204, , lot# p11693, manf date: 28-jan-2016, exp date: 31-dec-2020, (b)(4).Based on the information, the event could not be confirmed.The products were not returned for analysis; however a review of the manufacturing documentation associated with these lots (c11960, p10635 and p11693) 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
As reported by health care professional, during a procedure coils failed to unsheathe properly and one did not detach.Orbit galaxy, catalog# 641cx2535, lot# c11960, orbit galaxy, catalog# 641cf0306, lot# p10635 and orbit galaxy, catalog# 64hx0204, lot# p11693 are the coils reported; however it is unknown which coil failed to detach and which coils failed to re-sheath.There were no adverse events reported.Patient information and procedure details are unknown.It was initially reported that the complaint devices are available for return.
Additional Manufacturer Narrative
This is one of one final mdr report being submitted for this complaint with associated mfr# 2954740-2016-00212.Please note that after receipt of additional information, the event does not meet the criteria for reporting.Therefore, no further information will be forthcoming for this med watch report.Additional information received from initial reporter on 11nov2016.It was reported that the malfunction against orbit galaxy coil , catalog# 641cx2535, lot# c11960 was "failed to strip" and not" failure to detach".Based on the new information received the orbit galaxy coil , catalog# 641cx2535, lot# c11960 does not meet criteria for mdr reporting.Please note that after receipt of additional information, the event does not meet the criteria for reporting.Therefore, no further information will be forthcoming for this med watch report.

• 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: 5971190
• Report Number: 2954740-2016-00212
• Device Sequence Number: 902429
• Product Code: HCG
• UDI-Device Identifier: 10878528008917
• UDI-Public: (01)10878528008917(17)170709(10)C11960
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 09/01/2016

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: 07/09/2017
• Device Catalogue Number: 641CX2535
• Device Lot Number: C11960
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2016
• Supplement Report FDA Received Date: 12/01/2016
• Patient Sequence Number: 1