MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1MM X 1CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLM910010
Medical Device Problem Codes	Stretched (1601); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2019
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: krd/hcg.Initial reporter phone: (b)(6).Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).[conclusion]: the healthcare professional reported that during the coil embolization procedure that was targeting an aneurysm on the posterior communicating artery (pcom), after the physician successfully advanced, detached, and implanted the 2mm x 6 cm galaxy g3 mini coil and the 1mm x 3cm galaxy g3 mini coil in the target lesion via the echelon¿ 10 microcatheter (medtronic), the 1mm x 1cm galaxy g3 mini coil (glm910010 / l11046) was chosen to finish the case.However, the coil would not advance into the echelon¿ 10 microcatheter.The delivery wire became bent with the force that was applied.The coil was removed, and the physician made another attempt with another 1mm x 1cm galaxy g3 mini coil from the same lot, but he encountered the same issue.The coil was replaced with the 1mm x 2cm target® nano¿ coil (stryker), but when it was advanced half way up the microcatheter, it also became jammed.The microcatheter was removed and the physician waited 20 minutes to see if the aneurysm was embolized with the previously implanted coils.After the 20-minute wait, a new echelon¿ 10 microcatheter and a new target® nano¿ coil were used to complete the procedure.The target position was maintained / rediscovered with the positioning of the new microcatheter.The patient was successfully treated without any adverse event or complication.Additional information was provided; there was no kink on the microcatheter as the first two galaxy g3 mini coils were successfully advanced.Adequate and continuous flush was maintained through the microcatheter during the procedure.When the 1mm x 1cm galaxy g3 mini coil was removed, the coil was still undetached as it did not reach the target lesion.There was no appearance of damage observed apart from the bent delivery wire from the forced applied during the attempt to advance it through the microcatheter.The concomitant devices used did not kink nor bend during the procedure.The product was returned for evaluation.The investigational finding is documented below.Investigation summary: the following three non-sterile devices were received contained in a pouch: two (2) 1mm x 1cm galaxy g3 mini coils and the concomitant echelon¿ 10 microcatheter (medtronic).This investigation is for one of the two galaxy g3 mini coils.Visual inspection was performed.The hub was observed without any damage.The device positioning unit (dpu) was observed kinked and protruded from the introducer, confirming the issue documented in the complaint, that the delivery wire became bent with the force that was applied.The introducer was partially unzipped and kinked.The resheathing tool was observed without any damage.The marker band was found 36cm from the hub; this is within specification.Microscopic inspection was performed.The v-notch was without any damage.The resistance heating (rh) was observed in good condition.The embolic coil was observed kinked and in stretched condition.The reported issue that the detachable coil delivery system was impeded in the microcatheter was not confirmed through functional testing as the returned device with the observed kinked dpu protruding from the introducer precluded it from undergoing functional evaluation.A review of manufacturing documentation associated with this lot (l11046) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The reported issue that the delivery wire became bent with the force that was applied during the attempt to advance the coil was confirmed.The dpu on the returned device was kinked and protruding from the introducer that was also kinked and partially unzipped.While coil stretching and kinking are known potential issues associated with the use of the device, the kinked and stretched condition of the embolic coil as observed under microscopic inspection was likely associated with the force that was applied during the attempt to advance the coil into the echelon¿ 10 microcatheter and became stretched and kinked as a result of this applied force.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 1mm x 1cm galaxy g3 mini coil left the manufacturing facility with the coil in the condition that was observed on the returned device.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 two products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2019-01154.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.
Event or Problem Description
The healthcare professional reported that during the coil embolization procedure that was targeting an aneurysm on the posterior communicating artery (pcom), after the physician successfully advanced, detached, and implanted the 2mm x 6 cm galaxy g3 mini coil and the 1mm x 3cm galaxy g3 mini coil in the target lesion via the echelon¿ 10 microcatheter (medtronic), the 1mm x 1cm galaxy g3 mini coil (glm910010 / l11046) was chosen to finish the case.However, the coil would not advance into the echelon¿ 10 microcatheter.The delivery wire became bent with the force that was applied.The coil was removed, and the physician made another attempt with another 1mm x 1cm galaxy g3 mini coil from the same lot, but he encountered the same issue.The coil was replaced with the 1mm x 2cm target® nano¿ coil (stryker), but when it was advanced half way up the microcatheter, it also became jammed.The microcatheter was removed and the physician waited 20 minutes to see if the aneurysm was embolized with the previously implanted coils.After the 20-minute wait, a new echelon¿ 10 microcatheter and a new target® nano¿ coil were used to complete the procedure.The target position was maintained / rediscovered with the positioning of the new microcatheter.The patient was successfully treated without any adverse event or complication.Additional information was provided; there was no kink on the microcatheter as the first two galaxy g3 mini coils were successfully advanced.Adequate and continuous flush was maintained through the microcatheter during the procedure.When the 1mm x 1cm galaxy g3 mini coil was removed, the coil was still undetached as it did not reach the target lesion.There was no appearance of damage observed apart from the bent delivery wire from the forced applied during the attempt to advance it through the microcatheter.The concomitant devices used did not kink nor bend during the procedure.The product was returned for evaluation which revealed that the embolic coil was stretched and in kinked condition.Based on the product analysis on 8/23/2019, this event has been deemed mdr reportable as a ¿malfunction.¿.

• Brand Name: GALAXY G3 MINI 1MM X 1CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 8947102
• Report Number: 3008114965-2019-01153
• Device Sequence Number: 16755200
• Product Code: KRD
• UDI-Device Identifier: 10886704080213
• UDI-Public: 10886704080213
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2019

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: GLM910010
• Device Lot Number: L11046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1