MAUDE Adverse Event Report: REFER TO SECTION H10 GALAXY G3 5MM X 10CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLY120510
Medical Device Problem Codes	Separation Failure (2547); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient age, gender, weight, medical history, race, and ethnicity was not provided.Procode: krd/hcg.(b)(4).Initial reporter - the customer contact information was not reported by the manufacturer representative.(b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.This is one of three products involved with the reported complaint and the associated manufacturer report numbers are 3008114965-2018-00745, and 3008114965-2018-00746.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
A report was received that during a coil embolization of an aneurysm, a total of three thermo-mechanical coils (two 1mm x 2cm galaxy g3 mini glm910020/l11499 and one 5mm x 10cm galaxy g3 gly120510/l11802) failed to detach in the target site.The sequence of events/timeline is unknown, but the user did change the connecting cable (unk catalog & lot) and detachment control box (unk catalog & lot) during the reported event with the same result.No other coils were deployed before or after the reported ones with the same connecting cable; however, it was reported that the dcb has been used to detach subsequent coils and has operated as intended.The coils were successfully removed from the patient without need for additional intervention.The procedure was completed with another vendor.A pre-deployment electrical check was performed.No patient complications occurred as a result of the event.The coils and connecting cable have been returned for evaluation.No further information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section b5: the complaint product was returned with the embolic coil mechanically detached and not returned for evaluation.Additional information received indicated that after multiple unsuccessful attempts to detach the coil, the coil was removed from the microcatheter.Upon removal from the proximal end of the unspecified microcatheter, the coil simply ¿fell off the delivery wire¿ onto the table.There was no additional attempt to detach the coil with the connecting cable, so the sales representative believes that the coil may have been loosened during retrieval through the microcatheter.The embolic coil was discarded after the procedure.[complaint conclusion].As reported by a healthcare professional, during an aneurysm coiling procedure, a total of three thermo-mechanical coils (two 1mm x 2cm galaxy g3 mini glm910020/l11499 and one 5mm x 10cm galaxy g3 gly120510/l11802) failed to detach in the target site.The sequence of events/timeline is unknown, but the user did change the connecting cable (unk catalog & lot) and detachment control box (unk catalog & lot) during the reported event with the same result.No other coils were deployed before or after the reported ones with the same connecting cable; however, it was reported that the dcb has operated as intended and has been used to detach subsequent coils.The coils were successfully removed from the patient without need for additional intervention.The procedure was completed with another vendor.A pre-deployment electrical check was performed.No patient complications occurred as a result of the event.The 5mm x 10cm galaxy g3 coil (l11802) was returned with the embolic coil mechanically detached and not returned for evaluation.Additional information received indicated that after multiple unsuccessful attempts to detach the coil, the coil was removed from the microcatheter.Upon removal from the proximal end of the unspecified microcatheter, the coil simply ¿fell off the delivery wire¿ onto the table.There was no additional attempt to detach the coil with the connecting cable, so the sales representative believes that the coil may have been loosened during retrieval through the microcatheter.The embolic coil was discarded after the procedure.No further information was provided.The 5mm x 10cm galaxy g3 device was returned with the original packaging, which matched the complaint information.The device was returned with the introducer unzipped completely so that the green introducer went into the distal end of the resheathing tool.The device was kinked at approximately 60 cm from the proximal end of the device.The product was returned with the embolic coil mechanically detached from the device and the embolic coil was not returned with the complaint.The distal end of the device positioning unit (dpu) core wire was advanced from the introducer.The device was then inspected under a microscope.The distal outer sheath was not softened, indicating that the resistance heating coil had not been heated and the detachment process had not been initiated.The v-notch of the resheathing tool was undamaged.The green introducer was seen entering the distal end of the resheathing tool.The device was connected to multimeter and the resistance was measured within specification.The device was then connected to an enpower detachment control box (dcb2000500/c46055) and an enpower connecting cable c10702.The dcb2 power was turned on and the system ready light illuminated.The ¿detach¿ button was pressed on the detachment control box.The distal outer sheath was seen softened, indicating that the resistance heating coil had successfully heated.A review of manufacturing documentation associated with this lot 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.The reported customer complaint that the coil failed to detach could not be confirmed.The device could not be fully tested for detachment due to the condition in which it was returned.The reported customer complaint that the coil prematurely detached in the microcatheter during removal was confirmed; however, the exact circumstances surrounding the reported event cannot be determined based on the condition of the returned device.The embolic coil was detached from the device and not returned for analysis.The distal outer sheath was returned not softened, so it is likely that embolic coil was detached mechanically by force, possibly during retraction of microcoil system.The detachment control box was not returned and could not be evaluated for functionality.However, the device resistance measured within specification and it was successfully connected to a lab-supplied enpower dcb2 and control cable with the system ready light illuminated.After the detachment button on the dcb2 was pressed, the distal outer sheath was examined and was noted to have been softened, indicating that the resistance heating coil had heated successfully.The mechanical detachment of the embolic coil and the kinks in the dpu core wire are indicators of excessive force applied to the device.The instructions for use (ifu) instructs the user to leave approximately 1 inch (2-3 cm) of the translucent introducer sheath visible on the distal end of the resheathing tool.Advancing the resheathing tool further than this will put strain on the distal end of the skive.This may cause the skive to remain open when attempting to resheathe the device and not re-form around the dpu.As a result, the dpu will not properly resheathe.100% of dpu core wires and 100% of articulating joints (embolic coil connections to the distal core wire) are inspected in-process.Thus, it is unlikely that the device left the manufacturing facility with the observed damage or with the embolic col not properly attached.Without the return of the concomitant detachment control box, the cause of the reported event cannot be determined.The returned connecting cable met resistance, connectivity, and remote functionality requirements.Failure to detach the embolic coil and premature detachment are known potential product failures associated with the use of the device.The ifu contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.Neither the product analysis nor the device history record review suggests that the failure could be related to the manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that procedural and handling factors may have contributed to the reported failure and damages noted on the returned system.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.This is one of three products involved with the reported complaint and the associated manufacturer report numbers are 3008114965-2018-00745, and 3008114965-2018-00746.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: GALAXY G3 5MM X 10CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7902486
• Report Number: 3008114965-2018-00747
• Device Sequence Number: 1706724
• Product Code: KRD
• UDI-Device Identifier: 10886704077503
• UDI-Public: 10886704077503
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2018

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: 03/31/2021
• Device Catalogue Number: GLY120510
• Device Lot Number: L11802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1