MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 4MM X 12CM

Catalog Number	GLY120412
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter phone: (b)(6).Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization, a 4mm x 12cm galaxy g3 coil (gly120412, l12926) was being used as a framing coil.The physician attempted to insert galaxy g3 coil into the microcatheter, however, it could not be inserted into the microcatheter (mc).After several attempts, the physician attempted to re-sheath the complaint product, but the complaint product unraveled in the microcatheter.The complaint product was replaced with another coil and the procedure was completed.The product will not be returned for the investigation.There was no damage to the device prior to use.The device was used and prepped as per the instructions for use (ifu).No excessive force was applied to the device.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by a healthcare professional, during a coil embolization, a 4mm x 12cm galaxy g3 coil (gly120412, l12926) was being used as a framing coil.The physician attempted to insert galaxy g3 coil into the microcatheter, however, it could not be inserted into the microcatheter (mc).After several attempts, the physician attempted to re-sheath the complaint product, but the complaint product unraveled in the microcatheter.The complaint product was replaced with another coil and the procedure was completed.There was no damage to the device prior to use.The device was used and prepped as per the instructions for use (ifu).No excessive force was applied to the device.No further information is available.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device l12926 number, and no non-conformances related to the reported complaint condition were identified.With the information available and without the product available for analysis, the reported customer complaints of ¿detachable coil delivery system (dcs) - impeded in microcatheter with no loss of cerebral target position¿ and ¿coil - unraveled/stretched-in microcatheter¿ could not be confirmed.Based on the device history record review, there is no indication that the events are related to the device manufacturing process.The exact cause of the events could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failures.Impeded in microcatheter is a known potential product failure associated with the use of the device.The ifu includes warnings and instructions for use to trouble shoot this type of situation.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: GALAXY G3 4MM X 12CM
• Common Device Name: GALAXY G3
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 8800820
• Report Number: 3008114965-2019-01091
• Device Sequence Number: 3039582
• Product Code: KRD
• UDI-Device Identifier: 10886704077480
• UDI-Public: 10886704077480
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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: 06/30/2021
• Device Catalogue Number: GLY120412
• Device Lot Number: L12926
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER