MAUDE Adverse Event Report: REFER TO SECTION H10 MICRUSFRAME10 3.5MM X 6.6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR100356
Medical Device Problem Codes	Stretched (1601); Component Misassembled (4004); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Procode: krd/hcg.(b)(6).Initial reporter - the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.(b)(6).The product is available for evaluation and testing and has been shipped by the (b)(4) affiliate; however, it has not been received to date (which is indicated as "other" ).Additional information will be submitted within 30 days of receipt.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by a healthcare professional, resheathing of the 3.5mm x 6.6cm micrusframe10 (mfr100356/l10187) thermo-mechanical coil was not possible since the coil had stretched.The coil was replaced, and the procedure was completed successfully without significant delay.No patient complications occurred as a result of the event.The product will be returned for evaluation.It was reported that the information provided for this complaint was all of the details that were known/available regarding this event.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report that the product has been returned for evaluation and testing; however, the engineering evaluation has not yet been completed.A review of manufacturing documentation associated with this lot l10187 presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Additional information will be submitted within 30 days of receipt.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).(conclusion): remove code "known inherent risk of device." [complaint conclusion] as reported by a healthcare professional, the 3.5mm x 6.6cm micrusframe10 (mfr100356/l10187) thermo-mechanical coil failed to resheath since the coil had stretched.The coil was replaced, and the procedure was completed successfully without significant delay.No patient complications occurred as a result of the event.It was reported that the information provided for this complaint was all of the details that were known/available regarding this event.The complaint unit was returned, and the returned label matched the complaint information.Upon receipt of the complaint device, visual inspection was conducted.The device was completely unzipped.The proximal end of the green introducer was positioned inside the distal end of the resheathing tool.The embolic coil was not attached to the device positioning unit (dpu) and the embolic coil was not returned for analysis.Kinks were observed on the device positioning unit (dpu) core wire approximately 55 cm, 77 cm, and 134 cm from the proximal end of the device.After the visual inspection was conducted, an attempt was made to rezip the device; however, the introducer could not contain the core wire as it protruded from the skive.The device was then inspected under a microscope.The distal outer sheath had not softened, indicating that the resistance heating (rh) coil had not been heated and the detachment process had not been initiated.The distal outer sheath was seen damaged as it suffered an external tear.The v-notch of the resheathing tool was undamaged.The skive of the introducer was seen widened at the area of protrusion by the dpu core wire.The distance between the distal end of the strain relief valve and the distal end of the distal fluoro-saver marker was measured to be 41.0 cm, which is out of specification of 42.0 cm +/- 0.5 cm.All of the gaps between the markers were within specification of 4-6 cm.There were no signs of stress applied to the markers or surrounding dpu area.The markers appeared to have been shrunk appropriately.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 nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.An internal corrective action has been opened to address the distal fluoro-marker nonconformity.The corrective action is unrelated to coil unraveling/stretching or coil introducer zipping difficulty failures.The position of the distal fluoro marker is not a cause of embolic coil stretching or introducer zipping difficulties.The customer report of coil unraveled/stretched could not be confirmed since the embolic coil was not returned for evaluation.The device was seen with the indications that the coil was mechanically detached (the distal outer sheath had not softened, which is caused by the detachment process heating the resistance heating coil).The exact circumstances surrounding the observed mechanical detachment cannot be determined based on the condition of the returned device.There is no further information available regarding the embolic coil.The tear on the distal outer sheath may indicate that a sharp tool was used on the device.The premature detachment of the coil, along with the kinks in the dpu core wire, are indicative of the application of excessive force, possibly in an attempt to overcome resistance.The customer report of rezipping difficulty was confirmed.The device could not be re-zipped.The dpu core wire protruded from the introducer skive when an attempt was made to re-zip the device.The skive had been widened at this location.In addition, the green introducer had been brought to the distal end of the resheathing tool.The instructions for use (ifu) instructs the user to leave approximately 1 inch (2-3 cm) of the translucent introducer sheath visible on the distal end of the resheathing tool.Advancing the resheathing tool further than this will put strain on the distal end of the skive.This may cause the skive to remain open when attempting to resheathe the device and not re-form around the dpu.As a result, the dpu will not properly resheathe.Zipping functionality is verified in-process on all devices.Thus, it is unlikely that the device left the manufacturing facility with the observed failure.Rezipping difficulty, coil stretching, and premature detachment are known potential products failures associated with the device.The ifu contains several cautions relating to these situations, including instructions for troubleshooting the situations should they be encountered during use.The ifu states the following: ¿if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw and examine the delivery catheter system.If the microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.Do not attempt to use the microcoil system as a guidewire if positioning of the microcatheter is lost during microcoil deployment.If repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.¿ neither the device history record review nor the product analysis suggests that the reported failures could be related to the manufacturing process of the unit.Assignment of root cause for the event remains speculative and inconclusive, based on the minimal information provided and the evidence presented by the sample article; however, it is possible that procedural and handling factors, including device manipulation, may have contributed to the reported failure and damages noted to the returned system.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: MICRUSFRAME10 3.5MM X 6.6CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8073787
• Report Number: 3008114965-2018-00806
• Device Sequence Number: 1721074
• Product Code: KRD
• UDI-Device Identifier: 10886704077794
• UDI-Public: 10886704077794
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2018

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: 09/30/2020
• Device Catalogue Number: MFR100356
• Device Lot Number: L10187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 12/03/2018; 01/17/2019
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 12/12/2018; 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1