MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME18 11MM X 37CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR181137
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an external carotid artery embolization due to a gunshot wound, the physician encountered issues with four (4) coils.The first two coils, a 11mm x 37cm micrusframe 18 (mfr181137 / 30537032) and a 12mm x 40cm micrusframe 18 (mfr181240 / 30670821) would not detach after more than five (5) cycles were made to attempt to detach them.The third coil, a 1.5mm x 2cm deltaxsft 10 (dlx100152 / 30633423) and the fourth coil, a 1.5mm x 3cm deltaxsft 10 (dlx100153 / 30652463) would not advance due to broken string on the lock mechanism.The physician moved to a different product to finish the procedure.There was no report of injury to the patient.The procedure was successfully completed.On 13-jul-2023, additional information was received.The information indicated that the patient is a male under 18 years of age.The concomitant microcatheter used for all the coils was a 0.017 id headway® duo 156 microcatheter (microvention).The additional information related to the 11mm x 37cm micrusframe 18 (mfr181137 / 30537032) indicated the following: the coil was not stretched when it was removed, it was still attached to the delivery system.A pre-deployment electrical check was performed.No fault light was seen.Upon pressing the power button, all lights illuminated.The green system ready light did illuminate and the audible signal beep was heard.All connection fit properly without application of excessive force.The additional information related to the 12mm x 40cm micrusframe 18 (mfr181240 / 30670821) indicated the following: the coil was not stretched when it was removed, it was still attached to the delivery system.A pre-deployment electrical check was performed.Fault light was seen during the use of this coil.Upon pressing the power button, all lights illuminated.The green system ready light did illuminate and the audible signal beep was heard.All connection fit properly without application of excessive force.The related to the remaining two coils: 1.5mm x 2cm deltaxsft 10 (dlx100152 / 30633423) 1.5mm x 3cm deltaxsft 10 (dlx100153 / 30652463), continuous flush was maintained through the microcatheter during the procedure and during the use of both of these coils.Per the additional information, three (3) flush systems used: one (1) to the sheath, 1 to the guide and 1 to the microcatheter.The additional information indicated that reported issues did result in a non-clinically significant but frustrating delay in the procedure.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30537032) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.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.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.With the information available and without the complaint product available to be returned for analysis, the reported issue documented in the complaint 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 may have contributed to the reported failure.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00482 and 3008114965-2023-00483.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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.

• Brand Name: MICRUSFRAME18 11MM X 37CM
• 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): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 17379487
• Report Number: 3008114965-2023-00482
• Device Sequence Number: 12337845
• Product Code: KRD
• UDI-Device Identifier: 10886704078074
• UDI-Public: 10886704078074
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2023

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: 02/29/2024
• Device Catalogue Number: MFR181137
• Device Lot Number: 30537032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2021
• 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: HEADWAY® DUO 156 MICROCATHETER (MICROVENTION)
• Patient Sex: Male