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

Catalog Number MFR100253

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2017

Event Type  malfunction  

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 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
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 6507325
• MDR Text Key: 73254517
• Report Number: 2954740-2017-00087
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10886704077770
• UDI-Public: (01)10886704077770(17)190731(10)S11567
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: MFR100253
• Device Lot Number: S11567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1