MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME COIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR100253
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Procode: krd/hcg.Conclusion: the micrusframe coils were not available for analysis.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The positioning and resheathing difficulties could not be confirmed without product return for analysis.The root cause of the events could not be determined; however, procedural/handling factors may have contributed to the events.Since there was no evidence to suggest the events were related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.
Event or Problem Description
As reported by a healthcare professional, during treatment of a small 3.8 x 3.6mm middle cerebral artery aneurysm a micrusframe (mfr100253/s11567) could not be re-sheathed and a second micrusframe (same catalog and lot) was difficult to position in the aneurysm.While attempting to access the aneurysm with the first coil, the sl 10 microcatheter did not hold its position.The coil could not be re-sheathed and was removed from use.The coil did not appear damaged (i.E.Kinked, stretched, separated, detached), and a continuous flush had been maintained through the microcatheter.Next, a prowler lpes was placed and the second micrusframe was advanced; however, the coil did not take a proper shape and the physician kept trying to push the device, and it protruded into the parent vessel.It was reported that it only protruded into the vessel for a second and then was re-positioned.The coil would not oppose to the wall or open properly.The physician exchanged the coil for a competitor¿s coil and completed the procedure by successfully placing 5 coils of varying sizes using the same prowler lpes microcatheter.It was reported that the procedure was delayed 30 minutes due to the two events, but there was no patient injury.It was reported that the devices would not be returned for analysis.

• Brand Name: MICRUSFRAME COIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6507325
• Report Number: 2954740-2017-00087
• Device Sequence Number: 1641943
• Product Code: HCG
• UDI-Device Identifier: 10886704077770
• UDI-Public: (01)10886704077770(17)190731(10)S11567
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2017

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: 07/31/2019
• Device Catalogue Number: MFR100253
• Device Lot Number: S11567
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2017
• Initial Report FDA Received Date: 04/20/2017
• Patient Sequence Number: 1