MAUDE Adverse Event Report: MICRUSFRAME14 4MM X 8CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR140408
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: guidewire (succeed), microcatheter (1018) and dcb02.(b)(4).The name of the initial reporter is unknown.The manufacturer representative was provided as the initial reporter name.Information regarding patient age, weight, race, ethnicity, and medical history were not provided.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by an affiliate, during a coil embolization of an aneurysm of the bronchial and non-bronchial (bae) at the pulmonary artery, after a coil (deltafill4x15) was detached, the mcrusframe14(mfr140408, s13017) was inserted without any resistance.The coil was connected to the cable and attempted to detach but the coil could not be detached.The physician tried to detach the coil several times, the cable was replaced and the coil was flushed but the issue continued.Therefore, the coil was replaced with another one.The procedure was successfully completed without further issues or delay.There was also no patient injury or complications reported.The product will be returned for the investigation.The micrusframe14 coil was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and constant flush had been maintained at all time.It was approximately 2 mm of vessel embolus.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.A guidewire (succeed), microcatheter (1018) and dcb02 were also used for this procedure.The patient¿s vessel was not torturous and not calcified.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information received indicated that the microfram10 coil was successfully removed from the patient.The coil was still attached to the delivery system when removed from the patient.An old dcb (black) and an enpower dcb (blue) was used with the coil.The same dcb was used to detach subsequent coils.Complaint conclusion: as reported by an affiliate, during a coil embolization of an aneurysm of the bronchial and non-bronchial (bae) at the pulmonary artery, after a coil (deltafill4x15) was detached, the mcrusframe14(mfr140408, s13017) was inserted without any resistance.The coil was connected to the cable and attempted to detach but the coil could not be detached.The physician tried to detach the coil several times, the cable was replaced and the coil was flushed but the issue continued.Therefore, the coil was replaced with another one.The procedure was successfully completed without further issues or delay.There was also no patient injury or complications reported.The micrusframe14 coil was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and constant flush had been maintained at all time.It was approximately 2 mm of vessel embolus.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.A guidewire (succeed), microcatheter (1018) and dcb02 were also used for this procedure.The patient¿s vessel was not torturous and not calcified.Additional information received indicated that the microfram10 coil was successfully removed from the patient.The coil was still attached to the delivery system when removed from the patient.An old dcb (black) and an enpower dcb (blue) was used with the coil.The same dcb was used to detach subsequent coils.The micrusframe14 coil was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The distal portion of the embolic coil is located in the green introducer.There is a kink in the device positioning unit (dpu) core wire approximately 49 cm from the proximal end.The ball tip is intact.The embolic coil is kinked in several locations.The embolic coil is stretched near the articulating joint.The articulating joint is intact.The condition of the resistance heating (rh) coil is obscured by the translucent introducer sheath.Because of the damage to the embolic coil, the device cannot be advanced out of the introducer to visualize the rh coil.The v-notch of the resheathing tool is undamaged.The resistance of the device was measured.Resistance measured 64.2 ¿, which is outside the specification range of 48.5 ¿ 56.The device was connected to lab detachment control box (b)(4) with lab enpower control cable (b)(4) and the power was turned on.The system ready light did not illuminate.Detachment cannot be tested because the damage to the embolic coil prevents it from being advanced out of the introducer.Detachment also cannot be tested because the device resistance is out of specification.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 embolic coil failed to detach cannot be confirmed.Because of damage to the embolic coil, the device cannot be advanced out of the introducer in order to determine whether a detachment cycle had been successfully initiated.The returned device has a kink in the dpu core wire, measures out of specification for resistance, and does not cause the system ready light to illuminate when connected to a dcb2.The exact circumstances of the event were not reported, so it is not known whether the system ready light illuminated during the attempt to detach, nor whether the detach light illuminated or the audible signal was heard when the detach button was pressed.The kinks and stretched section of the embolic coil and the kinked dpu core wire are evidence of the application of excessive force to the device.The damage to the embolic coil prevents it from being advanced out of the introducer.Since the event description indicates that the embolic coil was placed in the aneurysm when detachment was attempted, the observed damage was not present when device use was initiated, and therefore must have occurred during the procedure, after the embolic coil was removed, or later.Per the ifu, the user to is verify that the coil delivery system is fully connected and no faults are indicted on the dcb.If a fault exists, reseat all connections between the dpu, the dcb, and the connecting cable.If a fault still persists, replace the connecting cable.If this does not correct the error, replace the dcb.If the coil delivery system still continues to have a fault, retrieve the device, re-sheathing the coil system, and replace with a new one.Devices are inspected in-process by advancing the embolic coil out of the introducer and retracting it again.Damage to the embolic coil would be detected at this inspection.Thus, it is very unlikely that the device left the manufacturing facility with the observed damage, or with the resistance out of specification as returned.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: MICRUSFRAME14 4MM X 8CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• MDR Report Key: 7177891
• Report Number: 3008114965-2018-00508
• Device Sequence Number: 956439
• Product Code: KRD
• UDI-Device Identifier: 10886704077985
• UDI-Public: (01)10886704077985(17)191231(10)S13017
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 12/18/2017

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: 12/31/2019
• Device Catalogue Number: MFR140408
• Device Lot Number: S13017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1