MAUDE Adverse Event Report: REFER TO SECTION H10 MICRUSPHERE XL 10MMX28CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	SSR18102820
Medical Device Problem Codes	Stretched (1601); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient age/date of birth, gender, weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.(b)(4).(b)(6).(b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.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, during a coil embolization of a subarachnoid hemorrhage due a ruptured intracranial aneurysm, the user had difficulty positioning the 10mm x 28cm micrusphere xl (ssr18102820/s11055) thermo-mechanical coil in the target site as the coil did not conform to the walls of the aneurysm and the shape of the coil did not appear as expected.The coil was partially deployed and partially in the echelon-10 (medtronic) microcatheter.The microcatheter lost its position as a result of the event.The user removed the coil, but the coil failed to resheath.The coil was replaced, and the procedure was completed successfully.The same microcatheter was used to complete the case.There was no report of consequence or impact to the patient.The surgery was delayed five minutes due to the event.The device was stored and handled according to the instructions for use (ifu).An adequate and continuous flush was maintained through the microcatheter.The device was prepped without any difficulty.The introducer did not appear damaged.There was no difficulty encountered unsheathing the introducer tube from the delivery tube of the device and the coil/device positioning unit (dpu)/delivery wire did not herniate out of the introducer.No visible damage was noted to the embolic coil when the device was removed from the patient.The user did not apply undue force at any time.The product will be returned for evaluation.No further information could be obtained.
Additional Manufacturer Narrative
(b)(4).As reported by a healthcare professional, during a coil embolization of a ruptured intracranial aneurysm, the user encountered difficulty positioning the 10mm x 28cm micrusphere xl (b)(4) coil in the target site as the coil did not conform to the walls of the aneurysm and the shape of the coil did not appear as expected.The coil was partially deployed and partially in the echelon-10 (medtronic) microcatheter.The microcatheter lost its position as a result of the event.The user removed the coil, but the coil failed to resheath.The coil was replaced, and the procedure was completed successfully.The same microcatheter was used to complete the case.There was no report of consequence or impact to the patient.The surgery was delayed five minutes due to the event.The device was stored and handled according to the instructions for use (ifu).The device was prepped without any difficulty and an adequate and continuous flush was maintained through the microcatheter.The introducer did not appear damaged.There was no difficulty encountered unsheathing the introducer tube from the delivery tube of the device and the coil/device positioning unit (dpu)/delivery wire did not herniate out of the introducer.No visible damage was noted to the embolic coil when the device was removed from the patient.The user did not apply undue force at any time.No further information could be obtained.A non-sterile 10mm x 28cm micrusphere xl was received inside of a pouch.The original packaging label was not returned with the complaint product.Upon receipt of the complaint device, visual inspection was conducted.The hub connector was undamaged.The device positioning unit (dpu) core wire was seen kinked at 2, 91, and 140 cm from the proximal end.The introducer was kinked.The resheathing tool was found separated.The resistance heating (rh) coil, the articulating joint, and the embolic coil were found inside of the introducer sheath.There were no other visual anomalies observed during the visual inspection.The device was then examined under a microscope.The anomalies noted during visual inspection were confirmed.The embolic coil was seen stretched.The embolic coil distal ball tip was present and intact.The distal outer sheath was not softened, indicating that the rh coil had not been heated and the detachment process had not been initiated.Functional testing could not be performed since the embolic coil was stretched and the introducer was kinked.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.All product rejected during manufacturing was identified as scrap and properly accounted for.The customer report of positioning difficulty cannot be confirmed because positioning difficulty is specific to both procedure and situation and cannot be reproduced or tested in the lab.However, the observed damage to the dpu core wire and embolic coil may make it more difficult to achieve correct positioning.The coil was stretched and unable to re-form its shape properly.The customer report of rezipping difficulty was confirmed.The translucent introducer sheath would not be able to re-form around the dpu because of the kinked condition of the introducer; however, functional testing could not be performed to determine potential causes of the rezipping failure due to the condition of the returned device.While the sequence of events leading to the observed damage to the embolic coil, dpu wire, and introducer cannot be determined based on the condition of the returned device, stretching and kinking typically occurs when an excessive retraction force is applied in the presence of resistance.The ifu instructs on proper positioning of the microcoil system.The ifu also warns: ¿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¿.100% of embolic coils are inspected for damage as well as correct shape during manufacturing inspection.Thus, it is unlikely that the device left the manufacturing facility with the observed damage.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 clinical and procedural factors, including device selection, vessel characteristics, device manipulation, and interaction with the concomitant microcatheter, 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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).The purpose of this mdr submission is to report the results of the device history record review.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.All product rejected during manufacturing was identified as scrap and properly accounted for.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.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.

• Brand Name: MICRUSPHERE XL 10MMX28CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8253406
• Report Number: 3008114965-2019-00883
• Device Sequence Number: 16675347
• Product Code: KRD
• UDI-Device Identifier: 00878528009900
• UDI-Public: 00878528009900
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K073442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2018

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: 06/30/2021
• Device Catalogue Number: SSR18102820
• Device Lot Number: S11055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 01/16/2019; 03/04/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 01/21/2019; 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECHELON-10 (MEDTRONIC) MC; ECHELON-10 (MEDTRONIC) MC