MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 4MM X 12CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLY120412
Medical Device Problem Codes	Product Quality Problem (1506); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during a coil embolization with the target being a pulmonary arteriovenous malformation (pavm), an excelsior® sl-10® microcatheter (stryker) was inserted into a balloon catheter (unspecified brand) and coil embolization was started by inflating the balloon catheter.The physician judged the coil embolization was difficult only at the feeder, therefore, ¿a frames¿ coil was used from inside the sac.The complaint coil, a 4mm x 12cm galaxy g3 (gly120412 / 30747550) was used when the proximal blood vessel was embolized by packing inside the sac.The complaint coil reportedly fit, but the shape was not proper.It was re-sheathed to adjust the position of the microcatheter.However, the sheath got torn and unable to be restored.The complaint coil was replaced with another coil and the procedure was completed.Continuous flush was maintained during the procedure.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Procode is krd/hcg.Initial reporter name and address: the name, phone and email address of the initial reporter are not available / reported.Device evaluated by mfr: the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (30747550) 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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.This information was not provided in the reported event or available at the time of report submission.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab on 11-oct-2022.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.10.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 14-oct-2022.[additional information]: on 14-oct-2022, additional information was received.The information indicated that coil placement was attempted but the coil shape was not able to wind as expected.Photos of the coil and of the product label are not available.The information also indicated that only the complaint product is available for return, the product packaging is not available.E.1: initial reporter phone:(b)(6).Updated sections: b.4, e.1, e.3, g.3, g.6, h.2, and h.10.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during a coil embolization with the target being a pulmonary arteriovenous malformation (pavm), an excelsior® sl-10® microcatheter (stryker) was inserted into a balloon catheter (unspecified brand) and coil embolization was started by inflating the balloon catheter.The physician judged the coil embolization was difficult only at the feeder, therefore, ¿a frames¿ coil was used from inside the sac.The complaint coil, a 4mm x 12cm galaxy g3 (gly120412 / 30747550) was used when the proximal blood vessel was embolized by packing inside the sac.The complaint coil reportedly fit, but the shape was not proper.It was re-sheathed to adjust the position of the microcatheter.However, the sheath got torn and unable to be restored.The complaint coil was replaced with another coil and the procedure was completed.Continuous flush was maintained during the procedure.There was no report of any patient adverse event or complication.On 14-oct-2022, additional information was received.The information indicated that coil placement was attempted but the coil shape was not able to wind as expected.Photos of the coil and of the product label are not available.The information also indicated that only the complaint product is available for return, the product packaging is not available.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 4mm x 12cm galaxy g3 was received contained in the decontamination pouch.Visual inspection was performed.The core wire was observed protruding from the introducer.Microscopic inspection was performed.Under magnification, the embolic coil was noted to be in good condition (i.E., no stretch, no elongation) inside the introducer.The introducer component was inspected and was found opened by a kink at the point where the core wire is protruding from.The damages noted on the introducer impacts the zipping functionality; this condition confirms the allegation documented in the complaint of premature peeling since the core wire was observed protruding from the introducer.Such damages seem to be secondary to the zipping difficulty condition reported and may relate to factors not described in this complaint (e.G., excessive force applied to the device).The device history record (dhr) for lot number 30747550 was reviewed.It noted that the embolic coil shape was inspected in accordance with the manufacturing procedures.These inspections were performed by different operators based on acceptance criteria as defined by such procedures.Additionally, all the pieces of this lot number passed the acceptance criteria for diameter distal loop and shape.The issue documented in the complaint regarding the coil being out of shape could not be confirmed since, during the inspection, no damages were found in the coil; also, during the review of the device history record (dhr), no abnormalities were found; the device passed the acceptance criteria.The customer complaint was not able to be confirmed.A review of manufacturing documentation associated with this lot (30747550) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instructions for use (ifu) contains the following precaution: appropriate selection of the detachable coil is critical to ensure device effectiveness and patient safety.Examine pre-embolization angiograms in order to choose the optimum device for any given lesion.It is important to select the optimum coil length, coil diameter, and coil type to ensure desired volumetric filling.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.H.6: the code ¿no device problem found (c19)¿ was used in the investigation findings because the reported issue of the coil being out of shape could not be confirmed.No damages were observed on the coil.A dhr review also indicated that the device passed the acceptance criteria.This code corresponds with the ¿cause not established (d15)¿ in the investigation conclusions.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 4MM X 12CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15526052
• Report Number: 3008114965-2022-00615
• Device Sequence Number: 2507205
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/20/2022

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: 02/28/2025
• Device Model Number: GLY120412
• Device Catalogue Number: GLY120412
• Device Lot Number: 30747550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 10/11/2022; 10/14/2022; 10/20/2022
• Initial Report FDA Received Date: 10/01/2022
• Supplement Report FDA Received Date: 10/11/2022; 10/14/2022; 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR® SL-10® MICROCATHETER (STRYKER)
• Patient Sex: Unknown