MAUDE Adverse Event Report: SEE H.10 GALAXY G3 9MM X 25CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLY120925
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).Initial reporter email address is not available / known.[conclusion]: the healthcare professional reported that during the venous fistula coiling procedure on normal venous anatomy targeting the transverse sinus, the 9mm x 25cm galaxy g3 coil (gly120925 / l10946) was reported to have issue advancing from the coil introducer.The coil was flushed again, but it still did not advance from the coil introducer.It was reported that the end user tried to unlock the coil from the locking tool, but the coil would not advance out of the introducer.The coil did not enter the microcatheter (excelsior¿ sl-10¿, stryker).It was confirmed that there was no damage noted on the galaxy g3 coil; no bend or kinks were noted on the microcatheter.The galaxy g3 coil was removed from the patient but the microcatheter was left in the patient.There was no report of any adverse event or patient consequence; there was no procedural delay associated with the reported issue.The 9mm x 25cm galaxy g3 coil was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the 9mm x 25cm galaxy g3 coil was returned with its original packaging.The packaging label matched the information documented in the complaint.The device was returned with the introducer completely removed from the resheathing tool.The distal end of the introducer escaped through the proximal end of the resheathing tool.The device positioning unit (dpu) core wire distal to the resheathing tool was seen protruding from the introducer skive.The distal end of the embolic coil was seen in the translucent introducer.Kinks were observed on the dpu core wire approximately 46 cm and 111 cm from the proximal end of the device.The device was then inspected under a microscope.The embolic coil distal ball tip was present and intact.The embolic coil was seen kinked at locations along its length.The articulating joint was seen intact.The distal outer sheath had not softened indicating that the detachment process had not been initiated.The v-notch of the resheathing tool was seen not damaged.When an attempt was made to advance the device, the coil became impeded in the introducer by being pressured against the inner walls of the introducer.A review of manufacturing documentation associated with this lot (l10946) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Investigation conclusion: the reported issue that the coil was impeded in the introducer was confirmed.The embolic coil could not be advanced from the introducer sheath due to the condition in which it was returned ¿ due to the kinks in the coil.There is not enough information in the complaint description to determine the cause of the reported failure.The complaint description did not document whether the flush was maintained prior to the first instance of advancement issue during the procedure.The instruction for use (ifu) provides instructions for when resistance is felt during device advancement through the delivery system.It is also possible that the device was subject to excessive force as indicated by the kinks in the embolic coil and dpu core wire, however it cannot be confirmed.The introducer completely removed from the resheathing tool indicates that the physician was not following the ifu for proper device preparation and placement into the delivery system.Devices undergo 100% test inspection for movement through the sheath.In addition, devices undergo 100% inspection at final assembly for damage to the embolic coil.The kinks observed along the length of the embolic coil would have devices undergo 100% test inspection for movement through the sheath.In addition, devices undergo 100% inspection at final assembly for damage to the embolic coil.The reported issue that the coil was impeded in the introducer was confirmed.The information provided in the complaint was not sufficient to determine conclusively the cause of the reported issue.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.It is possible that the circumstances of the procedure and/or the manipulation and interaction of the devices may have contributed to the reported issue.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are 3008114965-2018-00830.
Event or Problem Description
The healthcare professional reported that during the venous fistula coiling procedure on normal venous anatomy targeting the transverse sinus, the 9mm x 25cm galaxy g3 coil (gly120925 / l10946) was reported to have issue advancing from the coil introducer.The coil was flushed again, but it still did not advance from the coil introducer.It was reported that the end user tried to unlock the coil from the locking tool, but the coil would not advance out of the introducer.The coil did not enter the microcatheter (excelsior¿ sl-10¿, stryker).It was confirmed that there was no damage noted on the galaxy g3 coil; no bend or kinks were noted on the microcatheter.The galaxy g3 coil was removed from the patient but the microcatheter was left in the patient.There was no report of any adverse event or patient consequence; there was no procedural delay associated with the reported issue.The 9mm x 25cm galaxy g3 coil is available to be returned for evaluation and analysis.

• Brand Name: GALAXY G3 9MM X 25CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8149164
• Report Number: 3008114965-2018-00831
• Device Sequence Number: 1459826
• Product Code: KRD
• UDI-Device Identifier: 10886704077596
• UDI-Public: 10886704077596
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2018

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: 11/30/2020
• Device Catalogue Number: GLY120925
• Device Lot Number: L10946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1