MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME18 8MM X 30CM

Catalog Number	MFR180830
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Difficult to Remove (1528); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device l13636 number, and no non-conformances related to the reported complaint condition were identified.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).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 a healthcare professional, during a coil embolization, the user wanted to withdraw the 8mmx30cm micrusframe 18 coil (mfr180830, l13636) from the aneurysm, back into a sl10 microcatheter (mc), however, the coil seemed stuck.After some manipulation it became apparent that that the coil¿s resistant material had stretched and the coil protruded into patient artery.
Additional Manufacturer Narrative
(b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.As reported by a healthcare professional, during a coil embolization, the user wanted to withdraw the 8mmx30cm micrusframe18 coil (mfr180830, l13636) from the aneurysm, back into a sl10 microcatheter (mc), however, the coil seemed ¿stuck¿.After some manipulation it became apparent that that the coil¿s resistant material had stretched, and the coil protruded into patient artery.Multiple attempts to obtain additional information were unsuccessful.The device was discarded and therefore no further investigation can be performed at this time.A manufacturing record evaluation was performed for the finished device l13636 number, and no non-conformances related to the reported complaint condition were identified.With the limited information available and without the product available for analysis, the reported customer complaints of ¿coil - unraveled/stretched¿, ¿coil - protrusion into parent vessel¿, and ¿coil - withdrawal difficulty-into microcatheter¿ could not be confirmed.Based on the device history record review, there is no indication that the events are related to the device manufacturing process.The exact cause of the events could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failures.The instructions for use (ifu) cautions that if the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the catheter at or slightly inside the ostium of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.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 8MM X 30CM
• 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: 8800066
• Report Number: 3008114965-2019-01089
• Device Sequence Number: 10848548
• Product Code: KRD
• UDI-Device Identifier: 10886704078210
• UDI-Public: 10886704078210
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

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 Expiration Date: 07/31/2021
• Device Catalogue Number: MFR180830
• Device Lot Number: L13636
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/26/2019
• 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: SL10 MICROCATHETER