MAUDE Adverse Event Report: REFER TO SECTION H10 MICRUSFRAME18 8MM X 30CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR180830
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Based on the product analysis completed on 4/6/2018, this product complaint now meets the criteria for reporting as a malfunction under mdr regulations.Information regarding patient weight, medical history, race, and ethnicity was not provided.Procode: krd/hcg.(b)(4).Concomitant med products: dcb02 detachment control box, excelsior 1018 (stryker).Microcatheter, 4f contrast catheter, a terumo y-connector, enpower.(b)(6).(b)(4).Complaint conclusion: as reported by a healthcare professional, during a coil embolization of a gastroduodenal artery (gda) aneurysm, the 8 mm x 30 cm micrusframe18 (mfr180830/s14287) thermo-mechanical coil could not be properly placed in the target site; therefore, the physician attempted to resheath the coil.The introducer was delivered to the microcatheter hub.The physician tried to cover the device using the sleeve; however, ¿engagement was bad¿ and resistance was encountered.Furthermore, a part of the sleeve became damaged when it was lowered.The coil was replaced with a coil from the same catalog number.The procedure was completed with using 9 coils.The procedure was successfully completed without further issues or delay.There was no report of consequence or impact to the patient.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu).An excelsior 1018 (stryker) micro catheter was approached to the branch of the aneurysm and the micrusframe18 coil was selected for use.The coil was prepared according to ifu and coil embolization was initiated.A constant flush was maintained.No visible product damage was noted prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.The patient¿s vessel was neither tortuous nor calcified.A dcb02, a 4f contrast catheter, a terumo y-connector, and an enpower were also used for the case.Additional information received indicated that the user did not apply excessive force while unsheathing or resheathing.No further information was provided.The product was returned for investigation.The embolic coil was advanced out of the introducer and tangled around the device positioning unit (dpu) core wire.The device was gently untangled.The device was fully unsheathed.The resheathing tool was broken.There was blood in the translucent introducer sheath.There were bends in the dpu core wire approximately 46 cm and 48 cm from the proximal end.The ball tip was intact.There was blood on the embolic coil.The embolic coil was kinked.The articulating joint was intact.The resistance heating (rh) coil had not been heated.While the resheathing tool was broken, its v-notch was undamaged.There was a kink in the translucent introducer sheath near the proximal section of the resheathing tool.The product was microscopically inspected.An attempt was made to resheath the device.The device could not be resheathed; the dpu core wire protruded from the skive of the translucent introducer sheath.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The reported customer complaint of positioning difficulty could not be confirmed from the condition of the returned device.However, observed damage to the embolic coil could contribute to positioning difficulty.The reported customer complaint of rezipping difficulty was confirmed.A kink in the translucent introducer sheath, combined with the broken resheathing tool, caused the dpu core wire to protrude from the skive of the translucent introducer sheath when resheathing was attempted.The reported customer complaint that the introducer was damaged was confirmed.The resheathing tool was broken and there was a kink in the translucent introducer sheath.The device was returned with the embolic coil advanced out of the introducer and tangled around the dpu.In this condition, the embolic coil is more susceptible to damage than when it is encased in the protective introducer.Thus, it is possible that the observed damage to the embolic coil occurred after the reported event.100% of devices are inspected in-process for damage to the embolic coil.Thus, it is unlikely that the observed damage to the embolic coil was present when the device left the manufacturing facility.The broken resheathing tool is evidence of the application of excessive force to the device, likely during the reported resheathing difficulty.Based on the position of the proximal section of the resheathing tool, the device was unsheathed until the resheathing tool had passed over the green introducer.The ifu instructs the user to leave approximately 1 inch of the translucent introducer sheath visible at the distal end of the resheathing tool.Unsheathing past this point can cause the translucent introducer sheath to tear past the end of its skive, which will then prevent proper resheathing of the device.In addition, blood in the translucent introducer sheath and on the embolic coil suggests that insufficient flush was maintained.The ifu states that continuous infusion of an appropriate flush solution is required for optimal performance, and also indicates that the flush should be verified in the event of resistance.Insufficient flush allows blood to back-flow into the microcatheter, which can cause resistance.With review of the product analysis and the device history records, there is no indication of any manufacturing issues related to the reported event or damages noted on the returned system.Although a definitive conclusion cannot be made, it appears that procedural and handling factors addressed in the instructions for use may have contributed to the reported failure and damages observed on the returned device.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.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization of a gastroduodenal artery (gda) aneurysm, the 8 mm x 30 cm micrusframe18 (mfr180830/s14287) thermo-mechanical coil could not be properly placed in the target site; therefore, the physician attempted to resheath the coil.The introducer was delivered to the microcatheter hub.The physician tried to cover the device using the sleeve; however, ¿engagement was bad¿ and resistance was encountered.Furthermore, a part of the sleeve became damaged when it was lowered.The coil was replaced with a coil from the same catalog number.The procedure was completed with using 9 coils.The procedure was successfully completed without further issues or delay.There was no report of consequence or impact to the patient.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu).An excelsior 1018 (stryker) micro catheter was approached to the branch of the aneurysm and the micrusframe18 coil was selected for use.The coil was prepared according to ifu and coil embolization was initiated.A constant flush was maintained.No visible product damage was noted prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.The patient¿s vessel was neither tortuous nor calcified.A dcb02, a 4f contrast catheter, a terumo y-connector, and an enpower were also used for the case.Additional information received indicated that the user did not apply excessive force while unsheathing or resheathing.The product will not be returned for analysis.No further information was provided.

• Brand Name: MICRUSFRAME18 8MM X 30CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7424584
• Report Number: 3008114965-2018-00593
• Device Sequence Number: 1716408
• Product Code: KRD
• UDI-Device Identifier: 10886704078210
• UDI-Public: 10886704078210
• 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
• Report Date (Section B): 02/18/2018

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: 06/30/2020
• Device Catalogue Number: MFR180830
• Device Lot Number: S14287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR