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

Catalog Number MFR140512

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

This complaint met mdr reporting criteria when it was found during product analysis that the coil was kinked.Additional product codes: krd/hcg.Information regarding patient age, weight, gender and medical history were not provided.(b)(6).(b)(4).Conclusion: the tip coil and device positioning unit (dpu) core wire protruded from the skive of the translucent introducer sheath.The distal end of the embolic coil is located in the green introducer, near its distal end.There is blood in the green introducer and translucent introducer sheath.There are kinks in the dpu core wire approximately 4 cm and 80 cm from the proximal end.The ball tip is intact.There is blood on the embolic coil.The embolic coil is kinked.The articulating joint is damaged.The condition of the resistance heating (rh) coil is obscured by the translucent introducer sheath.There is blood on the articulating joint and rh coil.The dpu protrudes from the skive of the translucent introducer sheath starting at the marker band and continuing proximally.The v-notch of the resheathing tool is undamaged.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 dpu core wire is kinked was confirmed.The dpu core wire was kinked in two locations.The complaint that the prescore is ruptured was confirmed.The marker band, tip coil, and core wire sections of the dpu protrude from the skive of the translucent introducer sheath.The kinked embolic coil, damaged articulating joint, and kinked dpu core wire all suggest that excessive force was applied to the device, possibly in an attempt to overcome resistance.Resistance is likely a result of insufficient flush, as evidenced by the presence of blood along the embolic coil and articulating joint.The ifu states that continuous infusion of an appropriate flush solution is required for optimal performance, and also indicates that the flush should be verified in the event of resistance.Insufficient flush allows blood to back-flow into the microcatheter, which can cause resistance.In addition, the evidence of the protrusion of the marker band and tip coil indicate that the resheathing tool was advanced over these sections of the dpu while unsheathing the device.The ifu instructs the user to unsheathe a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the resheathing tool.This results in the placement of the embolic coil and the more flexible and fragile distal sections of the dpu inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing into the microcatheter, there is a risk that the embolic coil or the distal end of the dpu will be unsheathed and pass through the resheathing tool.If the resheathing tool passes over the distal end of the dpu, this will expose these flexible sections, which will then be subject to kinking and bending.Once a part of the dpu is kinked or bent, the translucent introducer sheath will not be able to re-form around it, and that section of the device will protrude.Since there was no evidence of a manufacturing issue related to the event, no corrective actions will be taken at this time.There are 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 events 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 of a bronchial artery aneurysm, the introducer of a micrusframe14 (mfr140512/ s13050) was inserted into the microcatheter and it was delivered, but the distal portion of the sheath of re-sheath tool was split open and the delivery wire exposed.It was difficult to advance and the physician tried to deliver, but it got kinked.Therefore, the coil was replaced with another one.The patient¿s information was unknown.The patient¿s vessel was not torturous and not calcified.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 product will be returned for the investigation.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: 7138199
• MDR Text Key: 95811485
• Report Number: 3013875781-2017-00049
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10886704077992
• UDI-Public: (01)10886704077992(17)191231(10)S13050
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: MFR140512
• Device Lot Number: S13050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1