MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME10 3.5MM X 6.6CM

Catalog Number	MFR100356
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.Date of event: the exact event date is unknown however it did occur in 2019.Procode: krd/hcg.Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).The company is seeking this information through the event investigation.This is one of three products involved with the complaint and the associated manufacturer report numbers are 3008114965-2019-01075 and 3008114965-2019-01077.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 healthcare professional, a galaxy g3 4mm x 12cm coil (gly120412, l12634), a micrusframe10 3.5mm x 6.6cm coil (mfr100356, lot unknown) and amicrusframe10 2.5mm x 3.3cm coil (mfr100253, l10193) coil would not detach once deployed into the aneurysm.There was no surgery delay due to the reported events.Another coil was advanced and deployed into aneurysm and the procedure was successfully completed.There were no patient consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 healthcare professional, a galaxy g3 4mm x 12cm coil (gly120412, l12634), a micrusframe10 3.5mm x 6.6cm coil (mfr100356, lot unknown) and a micrusframe10 2.5mm x 3.3cm coil (mfr100253, l10193) would not detach once deployed into the aneurysm.There was no surgery delay due to the reported events.Another coil was advanced and deployed into aneurysm and the procedure was successfully completed.There were no patient consequences to the patient.No additional information is available.The device will not be returned for analysis and therefore, no further investigation can be performed.The manufacturing record evaluation (mre) cannot be performed due to the lot number was not provided.With the information available and without the product available for analysis, the reported customer complaint of ¿coil ¿ failure to detach¿ could not be confirmed.An mre was not performed as the lot number was not available.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.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 limited information available and without the products available for analyses, the reported customer complaint could not be confirmed.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.

• Brand Name: MICRUSFRAME10 3.5MM X 6.6CM
• Common Device Name: MICRUSFRAME
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 8754756
• Report Number: 3008114965-2019-01076
• Device Sequence Number: 1708293
• Product Code: KRD
• UDI-Device Identifier: 10886704077794
• UDI-Public: 10886704077794
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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 Catalogue Number: MFR100356
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1