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

Catalog Number	MFR140408
Medical Device Problem Codes	Stretched (1601); Delivery System Failure (2905)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial mdr will be the only report submitted for mfr report #3013875781-2017-00003.Add'l product codes: krd/hcg (b)(4).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 micrusframe14 (mfr140408/s12445) was used during a coil embolization procedure of a cerebral aneurysm when the coil failed to detach.The micrusframe14 (complaint product) was connected to the cable during preparation, however, the green system ready light did not illuminate and therefore the coil could not be used for the procedure.It is unknown how the procedure was completed.The patient¿s information, including the vessel level of tortuousness and calcification, were unknown.No report of other devices used during this procedure is available.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 and after the event.No unintended detachment was observed in the vessel or in the micro catheter.The product will be returned for the investigation.No further information is available.
Additional Manufacturer Narrative
This final mdr will be the only report submitted for mfr report #3013875781-2017-00003.Additional information received on october 20, 2017: there was no damage noted to the coil, coil delivery system, or coil detachment system prior to the procedure.The event occurred during the electrical pre-test.The device was being used with an enpower dcb (dcb02).Reportedly, a pre-deployment electrical check was performed.Conclusion: the device was returned with its inner pouch.The labeling on the inner pouch matches the product documented in the complaint.The device is fully sheathed.The distal end of the embolic coil is located near the distal end of the green introducer sheath.There are no kinks or bends apparent in the device positioning unit (dpu) core wire.The ball tip of the embolic coil is intact.There are no kinks or stretched sections on the embolic coil.The articulating joint and resistance heating (rh) coil are obscured by the green introducer.The v-notch of the resheathing tool shows a small amount of damage along the sides.The embolic coil was advanced to expose the articulating joint and rh coil.There is a slight stretch in the embolic coil near the articulating joint.The articulating joint is intact.The rh coil has not received heat and melted.Device resistance was measured and found to be 53.4 ¿, which is within the specification.The device was connected to dcb2 with enpower control cable and the power was turned on.The system ready light illuminated.The embolic coil was immersed in warmed enzyme solution and the detach button was pressed.The embolic coil detached.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 not confirmed.The coil detached under laboratory conditions.The exact circumstances of the reported event are unknown, and without return of the dcb and connecting cable used during the event, its cause cannot be determined.There was a slight stretch, or gap, observed in the embolic coil near the articulating joint.Since the embolic coil detached in the laboratory, this observation is not likely to be related to the reported event.Coils are inspected for defects such as gaps and kinks 100% in-process, so it is unlikely that the device left the manufacturing facility with the observed damage.Without return of packaging and shipping materials, it cannot be determined whether the damage occurred in storage, during shipping, or when the device was being prepared and used.

• Brand Name: MICRUSFRAME COIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• MDR Report Key: 6951770
• Report Number: 3013875781-2017-00003
• Device Sequence Number: 10987694
• Product Code: KRD
• UDI-Device Identifier: 10886704077985
• UDI-Public: (01)10886704077985(17)190930(10)S12245
• 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,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup

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: 09/30/2019
• Device Catalogue Number: MFR140408
• Device Lot Number: S12445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 11/15/2017
• Patient Sequence Number: 1