MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME10 4MM X 7.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR100407
Medical Device Problem Codes	Separation Failure (2547); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.The initial reporter phone of the is not available / reported.The device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (l11516) 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.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.
Event or Problem Description
The healthcare professional reported that the 4mm x 7.5cm micrusframe 10 coil (mfr100407 / l11516) was used during a procedure targeting an aneurysm on the anterior communicating artery (acom).It was reported that the vessel was moderately tortuous.The complaint coil failed to detach during the detachment attempt, it became detached during retraction and was pushed into the aneurysm.The coil did not become fractured into separate pieces.The same microcatheter had been used on previous coils.The event did not result in any reduced or restricted blood flow in the parent vessel.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the returned complaint device on 11/13/2020.The returned product underwent evaluation and analysis.[conclusion]: the healthcare professional reported that the 4mm x 7.5cm micrusframe 10 coil (mfr100407 / l11516) was used during a procedure targeting an aneurysm on the anterior communicating artery (acom).It was reported that the vessel was moderately tortuous.The complaint coil failed to detach during the detachment attempt, it became detached during retraction and was pushed into the aneurysm.The coil did not become fractured into separate pieces.The same microcatheter had been used on previous coils.The event did not result in any reduced or restricted blood flow in the parent vessel.There was no report of any patient adverse event or complication.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 4mm x 7.5cm micrusframe 10 coil was received contained in a pouch.Visual inspection was performed.The marker band was found at 42cm from the hub; this is within specification.The embolic coil component was not returned for evaluation.No other anomalies or damages were observed.Microscopic inspection was performed.The resistance heating (rh) coil appeared overheated.A review of manufacturing documentation associated with this lot (l11516) 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.The complaint documented that during the procedure, the 4mm x 7.5cm micrusframe 10 coil failed to detach during the initiated detachment attempt.It became detached during the retraction and was pushed into the aneurysm.The failure to detach issue could not be confirmed as the embolic coil component was not returned; but the rh coil showed evidence of being heated, an indication that the detachment cycle was initiated.It appears overheated, which suggests that the detachment cycle may have been initiated more than one time.The premature detachment issue is confirmed as it was reported that the coil detached during retraction.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.Updated sections: d.6, d.10, g.4, g.7, 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.

• Brand Name: MICRUSFRAME10 4MM X 7.5CM
• 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: 10672098
• Report Number: 3008114965-2020-00433
• Device Sequence Number: 19581096
• Product Code: KRD
• UDI-Device Identifier: 10886704077824
• UDI-Public: 10886704077824
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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: 01/31/2021
• Device Model Number: MFR100407
• Device Catalogue Number: MFR100407
• Device Lot Number: L11516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1