MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME14 3MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR140306
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was noted as being stretched, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg (b)(6).Complaint conclusion: as reported by the field, during emergent coil embolization of a ruptured aneurysm at the renal artery, a 3mm x 6cm micrusframe14 coil (mfr140306, l16959) was used but the sheath got damaged.It was replaced with another same sized coil (same catalog number) and the procedure was completed.Additional information was received indicating that the complaint coil was used but it got stuck and the sheath got damaged.An unspecified concomitant microcatheter (inner 0.017 inches) was used.There was no blood flow restriction/reduction as a result of the event.The customer states there is no additional information available.A non-sterile unit micrusframe14 3mm x 6cm was received inside of a pouch.The device was visually inspected, and it was found that the introducer has a twisted condition, no other damages or anomalies were observed during the visual inspection.The embolic coil was inspected under a microscope and it was found stretched with dry blood residues on it.The functional test could not be performed due to the stretch condition noted on the embolic coil, and the twisted condition noted on the introducer.A manufacturing record evaluation (mre) was performed for the finished device l16959 number, and no non-conformances related to the reported complaint condition were identified.The reported customer complaint ¿coil introducer ¿ damaged¿ was confirmed.During the visual analysis of the device, it was noted that the introducer has a twisted condition.This condition is related to the customer¿s complaint regarding coil introducer damaged.Procedural and other factors may contribute to the finding; however, this cannot conclusively determine.A microscopic test was performed, and it was found that the embolic coil is stretch with dry blood residues on it.This condition could be related to the customer¿s complaint regarding an impeded condition.Procedural and other factors may contribute to the finding; however, this cannot conclusively determine.Based on the findings during the microscopic analysis, the customer¿s complaint was confirmed.Neither the device history record review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.It should be noted that product failure is multifactorial.The instructions for use do contain the following caution: do not fasten the rhv valve too tightly around the introducer sheath since excessive pressure may cause damage to the introducer sheath and/or the microcoil as it is advanced into the infusion microcatheter.Additionally, if the introducer tip and microcatheter hub are misaligned, damage may occur to the microcoil as it passes through this transition.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Assignment of root cause for the events remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.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, during emergent coil embolization of a ruptured aneurysm at the renal artery, a 3mm x 6cm micrusframe14 coil (mfr140306, l16959) was used but the sheath got damaged.It was replaced with another same sized coil (same catalog number) and the procedure was completed.Additional information was received indicating that the complaint coil was used but it got stuck and the sheath got damaged.An unspecified concomitant microcatheter (inner 0.017 inches) was used.There was no blood flow restriction/reduction as a result of the event.The customer states there is no additional information available.Based on the analysis of the device received, the embolic coil was noted as being stretched.

• Brand Name: MICRUSFRAME14 3MM X 6CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 11620040
• Report Number: 3008114965-2021-00140
• Device Sequence Number: 3920086
• Product Code: KRD
• UDI-Device Identifier: 10886704077961
• UDI-Public: 10886704077961
• 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
• Report Date (Section B): 01/24/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: MFR140306
• Device Catalogue Number: MFR140306
• Device Lot Number: L16959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/06/2021
• 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: UNSPECIFIED MICROCATHETER (INNER 0.017 INCHES)