MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM; ARTIFICIAL EMBOLIZATION DEVICE

Model Number N/A

Device Problems Difficult To Position (1467); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2015

Event Type  malfunction  

Event Description

The contact at the hospital reported that the doctor tried to fill an aneurysm at the anterior communicating artery with an orbit galaxy g2 (641cf0620/c26273) however had trouble positioning it and found that the coil may have been detached when trying to reposition.Additional intervention was attempted to retrieve the coil.The aneurysm was saccular, 11 mm wide and 16 mm long with a neck width of 4 mm.An envoy da (67125695d/lot not provided) and a headway 17 microcatheter (mc172150s/lot not provided) were used in the procedure.He tried to best position it, but it was protruding to the vessel.When he tried to pull back the wire with coil for the third time he noticed that there was no movement of the coil corresponding to pulling back on the proximal part of the dpu wire.Despite not feeling any friction, tension or any kind of obstacle, he realized the coil must have been detached from the wire.He reportedly did not even touch the detachment control box so he was sure he did not detach it himself.The doctor had to stop the embolization and tried to retrieve the coil with a lasso device but was not successful.Part of the coil remained in the aneurysm and part of it protruded into the vessel.The image seen during the procedure seems to show a shadow, which looked like a kind of fabric or gentle plastic fiber connected to the coil.The product was stored according to labeling instructions.The product was available for return.There was no significant delay to the procedure as a result of the issue.There was no flow restriction as a result of the issue.The bleeding from the target aneurysm stopped after the procedure.There was no additional adverse outcome to the patient.Two other aneurysms were left untreated although unrelated to the product issue.No neck remodeling was utilized.An adequate continuous flush was maintained through the microcatheter at all times.There was no resistance between the guidewire and microcatheter when accessing the target site.There was no resistance at any time during advancement of the coil through the microcatheter.Prior to this coil, 7 coils (details unknown) were placed in the aneurysm.There were no kinks in the microcatheter that may have contributed to the event.There was no resistance when the coil was advanced/repositioned/withdrawn.The microcatheter was not repositioned over the coil while the coil was deployed or partially deployed out of the distal end of the microcatheter.A one to one relationship between the coil and delivery tube was verified with fluoro prior to repositioning.

Manufacturer Narrative

The product is expected to be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.

Manufacturer Narrative

The embolic coil was implanted and not returned.Dhr: 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.The unidentified detachment control box (dcb) and connecting cable were not returned.The headway microcatheter was not returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition except for a section of dried contrast granules located under the resistive heating coils outer sheath which are difficult to clean.The system was either not used or was cleaned/rinsed before being returned which may have produced further damage.It is also unknown if the device was further manipulated and/or inspected post-procedurally.Any trace evidence that may have been complaint related may have been altered or removed prior to being returned.The coil was not returned as reported.Located 7.0 centimeters off the distal tip is a bent section of the core wire.Located 1.0 centimeters off the distal tip is a kinked section of the tip coil.Located 5 millimeters off the distal tip is a kink adjacent to the tapered resistive heating coils proximal section.The detachment of the coil appears to be mechanical in nature as no signs of heating and melting were found on the outer sheath surrounding the resistive heating coil section.No manufacturing defects were found.Positioning difficulty and premature detachment are known potential product malfunctions associated with use of the galaxy g2 coils and are listed with precautions in the ifu as such.All products undergo a 100% inspection prior to being released for sale; there is no evidence of a manufacturing issue related to this complaint.While the exact root cause of the coils positioning difficulty and unintended detachment cannot be determined, the most likely contributing factors to these difficulties may have occurred during repositioning.The coil may have had distal interference which contributed to the positioning difficulty and the evidence highly suggests that the coil became anchored on the coils already dwelling inside the aneurysm (if previously placed), on itself, or on the distal tip of the microcatheter.This interference may have bent the distal section of the device positioning unit (dpu) in multiple places.When the anchored coil was retracted for repositioning, the coil most likely was mechanically detached.If this occurred then for optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿caution: if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.Caution: if the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the catheter at or slightly inside the ostium of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.¿ in addition, without the return of implanted coil and the headway microcatheter used in the procedure, it cannot be determined if this component contributed to the complaint event.

• Brand Name: ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
• Type of Device: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: duane durbin ; 821 fox lane; san jose, CA 95131 ; 5088288310
• MDR Report Key: 4838247
• MDR Text Key: 5902731
• Report Number: 2954740-2015-00129
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K120686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 641CF0620
• Device Lot Number: C26273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/16/2015
• Initial Date FDA Received: 06/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/30/2015
• Date Device Manufactured: 05/13/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention