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

Catalog Number MFR100517

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

This event met mdr reporting criteria on 12/5/2017 when product analysis found that the coil was kinked.Information about patient age, weight, gender and medical history were not available.Concomitant medical products: a guiding catheter (7fr fubuki 90cm, asahi intecc), a microcatheter (sl10, stryker), a balloon catheter (hyperform 4*7, covidien (b)(4)) and an enpower control cable (ecb000182-00, s13420) were also used for this procedure.Customer information could not be provided.The (b)(4) affiliate is listed as the initial contact.Mfg name - codman & shurtleff, inc.Dba depuy synthes products, inc.Conclusion: the device was returned fully sheathed.The distal end of the embolic coil is located in the green introducer, near its distal end.A segment of the device positioning unit (dpu) has protruded from the translucent introducer sheath distal to the resheathing tool.There are no apparent kinks or bends in the dpu core wire.The ball tip is intact.The embolic coil is kinked.The condition of the articulating joint and resistance heating (rh) coil are obscured by the translucent introducer sheath.The translucent introducer sheath is damaged at the distal end of the protruded section of the dpu core wire.There is a slight amount of damage to the v-notch of the resheathing tool.Advancement of the embolic coil was attempted.The embolic coil was successfully advanced out of the introducer.The articulating joint is intact.The rh coil has not received heat and melted.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint that the device was impeded in the introducer is not confirmed.The embolic coil was successfully advanced out of the introducer under lab conditions.Damage observed to the translucent introducer sheath indicates that the device was not unsheathed carefully.According to the ifu, the introducer sheath is unlocked by gently pulling it away from the resheathing tool at a 45 degree angle.Pulling at a greater angle, or fully bending or kinking the translucent introducer sheath, will damage the sheath in such a way that it cannot re-form into a tube as it passes back through the resheathing tool during the resheathing operation.This will cause the core wire to protrude, and can prevent advancement of the device through the sheath.In this case, it was possible to unsheathe the device beyond the kink in the translucent introducer sheath, and so to advance the embolic coil out of the introducer.The observed kink in the embolic coil may have occurred as a result of the reported resistance to advancement.Damage to the v-notch of the resheathing tool is minimal and incidental to the reported event.The exact circumstances of the event are unknown, and the microcatheter and rhv were not returned.Without return of these devices, the cause of the reported event cannot be determined.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was 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 coil embolization for an anterior communicating artery aneurysm with subarachnoid hemorrhage, a micrusframe10 ((b)(4)) could not exit the introducer sheath, and during product analysis, it was found that the coil was kinked.The sheath was inserted into the y connector.After flushing, the micrusframe10 (complaint product) was attempted to be inserted, but the coil did not come out from the sheath, so the coil was removed from.About 10 centimeters of coil came out from the tip of the sheath, but coil was not advanced at all.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.The patient¿s information was unknown.The patient¿s vessel level of tortuousness and calcification were unknown.No further information is available.

• Brand Name: MICRUSFRAME COIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• Manufacturer Contact: joaquin kurz ; 47709 freemont blvd; freemont, CA 94538 ; 9497899383
• MDR Report Key: 7112822
• MDR Text Key: 95469287
• Report Number: 3013875781-2017-00046
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10886704077831
• UDI-Public: (01)10886704077831(17)191031(10)C40389R
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/26/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: MFR100517
• Device Lot Number: C40389R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1