MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME18 12MM X 40CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR181240
Medical Device Problem Codes	Retraction Problem (1536); Stretched (1601); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
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: procode/hcg initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The company is seeking this information through the event investigation.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 the field, this was a coil embolization for subarachnoid hemorrhage (sah) using a double catheter technique at the basilar artery (ba top).A 12mm x 40cm micrusframe18 coil was used together with a microcatheter (exselsior sl10).The complaint coil was used as framing coil but, it was unable to be framed as intended.The physician attempted to remove it but, it got stuck on the microcatheter and unraveled.The issue occurred inside the microcatheter (mc) therefore, it was removed together with the microcatheter.Another microcatheter and coil were used, and the procedure resumed and was completed.There were no post-procedure changes in the patient concomitant devices are a sheath introducer (terumo), a guidewire (asahi), a guiding catheter (asahi), y connector (terumo) and a detachment device (b)(4).
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).Updated sections on this medwatch: b4, b5, e1, e2, e3, g3, g6, h2, h6 and h10.Section b5: additional information received indicated that there was no excessive forced used with the device at any time.The event did not prolong the procedure.The concomitant devices functioned as expected.Section e1.Initial reporter phone: 087-898-5111 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 the field, this was a coil embolization for subarachnoid hemorrhage (sah) using a double catheter technique at the basilar artery (ba¿top).A 12mm x 40cm micrusframe18 coil was used together with a microcatheter (exselsior sl10).The complaint coil was used as framing coil but, it was unable to be framed as intended.The physician attempted to remove it but, it got stuck on the microcatheter and unraveled.The issue occurred inside the microcatheter (mc) therefore, it was removed together with the microcatheter.Another microcatheter and coil were used, and the procedure resumed and was completed.There were no post-procedure changes in the patient.Concomitant devices are a sheath introducer (terumo), a guidewire (asahi), a guiding catheter (asahi), y connector (terumo) and a detachment device (dcb2000500).Additional information received indicated that there was no excessive forced used with the device at any time.The event did not prolong the procedure.The concomitant devices functioned as expected.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30390754 number, and no non-conformances related to the malfunction were identified.Unraveled/stretched in microcatheter, withdrawal difficulties into microcatheter and positioning difficulties are known potential issues associated with the use of the device.With the information available and without the product available for analysis, the reported customer complaints could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the events are related to the device manufacturing process.The instructions for use (ifu) contains instructions and cautions regarding proper placement of the device, including introduction and positioning of the microcoil.Assignment of root cause for the events remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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: MICRUSFRAME18 12MM X 40CM
• 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 ; 6465917981
• MDR Report Key: 13950002
• Report Number: 3008114965-2022-00246
• Device Sequence Number: 20478210
• Product Code: KRD
• UDI-Device Identifier: 10886704078098
• UDI-Public: 10886704078098
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2022

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: 04/30/2023
• Device Model Number: MFR181240
• Device Catalogue Number: MFR181240
• Device Lot Number: 30390754
• 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: 03/16/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2020
• 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: ENPOWER DCB 2; EXSELSIOR SL10 MICROCATHETER; GUIDEWIRE (ASAHI); GUIDING CATHETER (ASAHI); SHEATH INTRODUCER (TERUMO); Y CONNECTOR (TERUMO)
• Patient Sex: Unknown