MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 6MM X 20CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	GLY120620
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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)).The healthcare professional reported that during the coil embolization procedure of an aneurysm, the 6 mm x 20 cm galaxy g3 coil (gly120620/ l12698) was selected and the physician attempted to put a coil loop in the target lesion.The coil became unraveled when the physician was trying to accommodate the coil loop in the aneurysm.The galaxy g3 coil was replaced and the procedure was successfully completed without further issues or delay.There was no report of patient injury or complications; the complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.There was no unintended detachment observed in the vessel or in the microcatheter.The product is not available to be returned for evaluation.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (l12698) 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.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation/interaction, aneurysm size/vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported unraveled coil.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Coil unraveled / stretched are known potential issues associated with the use of the device.The instruction for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 6 mm x 20 cm galaxy g3 coil left the manufacturing facility with the embolic coil in an unraveled stated.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 of failure to detach 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.
Event or Problem Description
The healthcare professional reported that during the coil embolization procedure of an aneurysm, the 6 mm x 20 cm galaxy g3 coil (gly120620/ l12698) was selected and the physician attempted to put a coil loop in the target lesion.The coil became unraveled when the physician was trying to accommodate the coil loop in the aneurysm.The galaxy g3 coil was replaced and the procedure was successfully completed without further issues or delay.There was no report of patient injury or complications; the complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.There was no unintended detachment observed in the vessel or in the microcatheter.The product is not available to be returned for evaluation.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to make a correction to the manufacture information, and to include the additional event information received on 5/8/2019.[conclusion]: the healthcare professional reported that during the coil embolization procedure of an aneurysm, the 6 mm x 20 cm galaxy g3 coil (gly120620/ l12698) was selected and the physician attempted to put a coil loop in the target lesion.The coil was withdrawn and re-inserted, during the coil withdrawal, it became unraveled.The galaxy g3 coil was successfully removed from the patient¿s body and replaced.The procedure was successfully completed without further issues or procedural delay.There was no blood flow restriction or reduction as a result of the reported event.It was confirmed that there were no kinks nor bends on the microcatheter prior to use.There was no report of patient injury or complications; the complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.There was no unintended detachment observed in the vessel or in the microcatheter.The product is not available to be returned for evaluation.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (l12698) 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.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation/interaction, aneurysm size/vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported unraveled coil.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Coil unraveled / stretched are known potential issues associated with the use of the device.The instruction for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 6 mm x 20 cm galaxy g3 coil left the manufacturing facility with the embolic coil in an unraveled stated.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 of failure to detach was related to a manufacturing or design issue, no corrective actions will be taken at this time.Initial reporter phone: (b)(6).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.

• Brand Name: GALAXY G3 6MM X 20CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CA CH-24 00; SZ CH-2400
• MDR Report Key: 8469780
• Report Number: 3008114965-2019-00945
• Device Sequence Number: 1784405
• Product Code: KRD
• UDI-Device Identifier: 10886704077541
• UDI-Public: 10886704077541
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2019

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: 05/31/2021
• Device Catalogue Number: GLY120620
• Device Lot Number: L12698
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1