MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME18 8MM X 30CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number MFR180830

Device Problems Material Separation (1562); Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2021

Event Type  malfunction  

Event Description

The healthcare professional reported that during an endovascular embolization procedure, the 5mm x 15cm galaxy g3 coil (gly120515 / 30558382) was used; it was resheathed as per the instructions for use (ifu) because its size did not fit the target lesion.However, the introducer sheath became damaged and it could not be resheathed.It was replaced with a 7mm x 21cm galaxy g3 coil (gly120721 / 30530861), but it was reported that this coil ¿flew¿ into the bloodstream.It was resheathed as per the ifu, but the sheath also became damaged and the coil could not be resheathed.It was then replaced with the 8mm x 30cm micrusframe 18 coil (mfr180830 / 30399412).This coil was implanted but it was unable to be detached with the enpower control cable (ecb00018200 / 30624693).The delivery wire was retracted and ¿as it was cut¿ therefore the catheter kicked back.It was reported that coil embolization was stopped and stent graft insertion was started.It was reported that the products are not available to be returned.There was no report of any patient adverse event or complication.On 13 dec 2021, additional information was received.The information indicated that the procedure was completed successfully.

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.The name, phone and email address of the initial reporter are not available / reported.Conclusion: the healthcare professional reported that during an endovascular embolization procedure, the 5mm x 15cm galaxy g3 coil (gly120515 / 30558382) was used; it was resheathed as per the instructions for use (ifu) because its size did not fit the target lesion.However, the introducer sheath became damaged and it could not be resheathed.It was replaced with a 7mm x 21cm galaxy g3 coil (gly120721 / 30530861), but it was reported that this coil ¿flew¿ into the bloodstream.It was resheathed as per the ifu, but the sheath also became damaged and the coil could not be resheathed.It was then replaced with the 8mm x 30cm micrusframe 18 coil (mfr180830 / 30399412).This coil was implanted but it was unable to be detached with the enpower control cable (ecb00018200 / 30624693).The delivery wire was retracted and ¿as it was cut¿ therefore the catheter kicked back.It was reported that coil embolization was stopped and stent graft insertion was started.It was reported that the products are not available to be returned.There was no report of any patient adverse event or complication.On 13 dec 2021, additional information was received.The information indicated that the procedure was completed successfully.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30399412) 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.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.Failure to detach is a known potential product issue associated with the use of the device.The ifu contains several cautions relating to these situations, including instructions for troubleshooting should they be encountered during use.Per the ifu: ¿if a fault light is detected, the system ready light is not illuminated, or there is no detachment after two detachment attempts, replace the dcb unit.If detachment still does not occur, carefully withdraw the entire microcoil system and redeploy a new microcoil system.¿ the complaint also reported that the delivery wire was retracted and ¿as it was cut¿ resulting in the microcatheter kicking back.It is not clear what ¿as it was cut¿ meant.However, without the product available to be returned for analysis, this issue cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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 issue.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 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00624.Missing information from this report is identified as blank; 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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 21-dec-2021.[additional information]: the healthcare professional reported that during an endovascular embolization procedure, the 5mm x 15cm galaxy g3 coil (gly120515 / 30558382) was used; it was resheathed as per the instructions for use (ifu) because its size did not fit the target lesion.However, the introducer sheath became damaged and it could not be resheathed.It was replaced with a 7mm x 21cm galaxy g3 coil (gly120721 / 30530861), but it was reported that this coil ¿flew¿ into the bloodstream.It was resheathed as per the ifu, but the sheath also became damaged and the coil could not be resheathed.It was then replaced with the 8mm x 30cm micrusframe 18 coil (mfr180830 / 30399412).This coil was implanted but it was unable to be detached with the enpower control cable (ecb00018200 / 30624693).The delivery wire was retracted and ¿as it was cut¿ therefore the catheter kicked back.It was reported that coil embolization was stopped and stent graft insertion was started.It was reported that the products are not available to be returned.There was no report of any patient adverse event or complication.On 13 dec 2021, additional information was received.The information indicated that the procedure was completed successfully.On 21 dec 2021, additional information was received.The information indicated that the 8mm x 30cm micrusframe 18 coil was successfully removed from the patient; it was not stretched when it was removed.A pre-deployment electrical check was performed.During the detachment attempt, the detachment light did not illuminate and the audible signal beep was not heard.All connections appear to fit without application of excessive force.It was confirmed that there was no allegation of any patient injury due to the reported issue.No additional intervention was required.The reported issue did not result in any clinically significant delay in the procedure.E.1: the initial reporter phone: (b)(6).The initial reporter email address is not available / reported.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00624 and 3008114965-2021-00625.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: MICRUSFRAME18 8MM X 30CM
• Type of Device: 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 13020681
• MDR Text Key: 290307069
• Report Number: 3008114965-2021-00625
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704078210
• UDI-Public: 10886704078210
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: MFR180830
• Device Catalogue Number: MFR180830
• Device Lot Number: 30399412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENPOWER CONTROL CABLE; GALAXY G3 5MM X 15CM; GALAXY G3 7MM X 21CM