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

Catalog Number 641CX0408

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2017

Event Type  malfunction  

Manufacturer Narrative

This is initial mdr report being submitted for this complaint with associated mfr# 2954740-2017-00190.Additional procode krd.(b)(4).Codman detachment device (dcb0000500/c38341) and the connecting cable (ccb00015700/p11121); detachment box dcb0000500/c38341 and connecting cable ccb00015700/p11121 the product is available for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.

Event Description

As reported by a health care professional, during a brain aneurysm embolization surgery, the codman detachment device (dcb0000500/c38341) and the connecting cable (ccb00015700/p11121) were used.Two galaxy g2 coils (641cf0515/ s12682 and 641cx0410/c32710), were successfully detached.However, galaxy coil (641cx0408/s10322) which was placed into the aneurysm failed to be detached during first attempt.After repeated detachment failure attempts with the above-mentioned coil, the detachment device and of the connecting cable were replaced with new items (new items: dcb0000500/c38341 and ccb00015700/p11121).However, in the end the coil couldn¿t be detached successfully and it was withdrawn from the aneurysm.The procedure was completed with a same like product.There were no patient injuries reported.It was initially reported that the complaint product is available for return.

Manufacturer Narrative

This is follow-up # 1 mdr report being submitted for this complaint with associated mfr# 2954740-2017-00190.Additional information received on 17jul2017.As reported by a health care professional, during a brain aneurysm embolization surgery, the codman detachment device (b)(4) and the connecting cable (b)(4) were used.Two galaxy g2 coils (b)(4), were successfully detached.However, galaxy coil (b)(4) which was placed into the aneurysm failed to be detached during first attempt.After repeated detachment failure attempts with the above-mentioned coil, the detachment device and of the connecting cable were replaced with new items (new items: (b)(4) and (b)(4).However, in the end the coil couldn¿t be detached successfully and it was withdrawn from the aneurysm.There was no stretching noted when the coil was removed from the patient and it was still attached to the delivery system.Reportedly, a pre-deployment electrical check was performed when using the complaint coil, upon pressing the power button all lights had illuminated and the green system ready light had also illuminated.During the detachment cycle the detachment light illuminated and the audible signal had beeped.All connections appeared to fit properly without application of excessive force.The procedure was then completed with a same like product.The same new items: (b)(4) and (b)(4) that were used to detach the complaint coil were used to detach the replacement coil.The procedure was coil of 9 mm anterior communicating artery aneurysm at a1-a2 junction in (b)(6) year-old-male patient.There were no patient injuries reported and the patient was reported to have fully recovered.There were no intra-procedure or post-procedural complications.It was initially reported that the complaint product is available for return.

Manufacturer Narrative

This is final mdr report being submitted for this complaint with associated mfr# 2954740-2017-00190.The device was returned with no damages noted on the device.The hub of the device was advanced to the proximal end of the resheathing tool.The resheathing tool was also near the green introducer indicating almost the full length of the translucent introducer was unzipped.The embolic coil was detached from the device positioning unit (dpu) however the resistive heating coil did not appear to receive heat and melt.The resistance of the device was tested and was within specification with a resistance of 52.0 ohms (48.5-56.0 ohms).The device was attached to the connecting cable and detachment control box and the system ready light illuminated.A detachment attempt was not made because the embolic coil was not attached.The complaint that the coil could not be detached was not confirmed.The device passed resistance testing and the system ready light illuminated when connected to the connecting cable and detachment control box.Although it was stated in the complaint that the embolic coil was attached to the dpu upon removal from the patient, on the returned device the embolic coil was not attached to the dpu.The circumstances of the detachment are unknown as the resistive heating coil did not appear to receive heat and melt the detachment fiber.Handling factors including shipping and packaging may cause the detachment.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.There is no current safety signal identified related to the reported event based on review of complaint history for the device.

• Brand Name: ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 6674297
• MDR Text Key: 78613614
• Report Number: 2954740-2017-00190
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10878528009372
• UDI-Public: (01)10878528009372(17)210331(10)S10322
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K120686
• 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,Followup
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 641CX0408
• Device Lot Number: S10322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 70