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

Catalog Number	MFR100517
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial mdr will be the only report submitted for mfr report #2954740-2017-00265.Additional product codes: krd/hcg.The product has been forwarded to codman for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that a micrusframe10 coil (mfr100517/s11573) was used during a coil embolization procedure of an aneurysm for a pediatric vv shunt where the coil could not be detached.The pre-deployment electrical check was performed with the micrusframe10 (complaint product) but the lamp did not blink when it was connected to the control box.The coil was replaced with another micrusframe10 coil (same catalog number).The patient was a (b)(6) female whose vessel was moderately tortuous, calcification was unknown.A guiding catheter (medikit) and a microcatheter (excelsior1018, stryker) were also used for this procedure.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 issue occurred during the pre-deployment electrical check.The product will be returned for the investigation.No further information is available.
Additional Manufacturer Narrative
This final mdr is the only report being submitted for mfr report #2954740-2017-00265.The device was returned with an inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The distal end of the embolic coil is located in the middle of the green introducer.There are no kinks or bends apparent in the device positioning unit (dpu) core wire.The ball tip is intact.The articulating joint appears to be intact.The resistance heating (rh) coil is obscured by the translucent introducer sheath.The v-notch of the resheathing tool is undamaged.The embolic coil was advanced out of the introducer to visualize the articulating joint and rh coil.The articulating joint is intact, and the rh coil has not received heat and melted.The resistance of the device was measured with multimeter.The resistance overloaded the multimeter, which is outside of the specification range of 48.5 ¿ 56 ¿.The device was connected to detachment control box dcb2000500 (dcb2) c46055 with enpower connecting cable c10702 and the power was turned on.The system ready light did not illuminate.Since the device fails the pre-deployment check, detachment functionality cannot be tested.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint that the coil failed to detach is confirmed.The device fails the resistance test and does not cause the system ready light to illuminate.As a result, a detachment cycle could not be initiated.This is consistent with the reported event.As there is no obvious physical damage to the device, the cause of the resistance failure cannot be determined.However, 100% of devices are tested for resistance after they are loaded into the packaging hoop.Thus, it is very unlikely that the damage leading to the overloaded resistance condition was present when the device left the manufacturing facility.Without the return of the remaining packaging and shipping materials, it is not possible to determine whether the damage occurred during storage, in transit, or when the device was prepared for use.There is no current safety signal related to the reported event based on a review of complaint history for the device.Therefore, no corrective actions will be taken at this time.

• 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: 6875077
• Report Number: 2954740-2017-00265
• Device Sequence Number: 19012397
• Product Code: KRD
• UDI-Device Identifier: 10886704077831
• UDI-Public: (01)10886704077831(17)190731(10)S11573
• Combination Product (Y/N): N
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2017

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: MFR100517
• Device Lot Number: S11573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Initial Date Received by Manufacturer: 08/24/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 11/20/2017
• Patient Sequence Number: 1
• Patient Age: 11 YR