MAUDE Adverse Event Report: MICRUSFRAME10 6MM X 26CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR100626
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This initial/final mdr will be the only report submitted for mfr report #3008114965-2018-00516.Procode: krd/hcg.(b)(4).Conclusion: two devices were returned commingled and with two inner pouches.Labeling on the inner pouches matches the product documented in the complaint.Both devices are the same lot number.The lot numbers are not marked on the device.For evaluation purposes, the devices were identified as device a and device b and labeled accordingly.{visual} device a: the introducer was not returned.The embolic coil is attached to the device positioning unit (dpu).The dpu core wire is kinked at the strain relief.Device b: the introducer was not returned.The embolic coil is attached to the dpu.There are no apparent kinks or bends in the dpu core wire.{microscopic} device a: the ball tip is intact.The embolic coil is kinked.The articulating joint is damaged.The resistance heating (rh) coil has not heated.Device b: the ball tip is intact.The embolic coil is kinked.The articulating joint is damaged.The rh coil has not heated.{functional} device a: advancement through a microcatheter cannot be tested because the introducer was not returned.Device b: advancement through a microcatheter cannot be tested because the introducer was not returned.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 devices were impeded in the microcatheter cannot be confirmed for either device.Since the devices were returned without their introducers, advancement through a microcatheter cannot be tested.Both embolic coils are kinked and both articulating joints are damaged.This is evidence that excessive force was applied to both devices, possibly in an attempt to overcome the reported resistance.The embolic coil and articulating joint are inspected in-process on 100% of, so it is unlikely that the devices left the manufacturing facility with these defects.There is no current safety signal identified related to the reported events based on review of complaint history for the devices.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.
Event or Problem Description
It was reported by a healthcare professional that two micrusframe 10 coils (mfr100626/c41675) were used during an aneurysm coiling procedure in the internal carotid artery (ica) when resistance was encountered.Both coils would not advance into the mc even though they were flushed as per ifu.Multiple other coils were used in case and worked.There was no patient injury as a result of the event and no medical intervention required.The patient¿s vessel was highly tortuous.There was no damage noted to the devices prior to use.There were no kinks or bends noted to the microcatheter that may have contributed to the reported event.No difficulty was experienced in removing the devices from the patient.The event resulted in a procedural delay of less than 30 minutes.The patient was a (b)(6) female who had a history of aneurysms.

• Brand Name: MICRUSFRAME10 6MM X 26CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• MDR Report Key: 7205829
• Report Number: 3008114965-2018-00516
• Device Sequence Number: 19013357
• Product Code: KRD
• UDI-Device Identifier: 10886704077862
• UDI-Public: 10886704077862
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 11/27/2017

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: 02/28/2019
• Device Catalogue Number: MFR100626
• Device Lot Number: C41675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Initial Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 45