MAUDE Adverse Event Report: REFER TO SECTION H10 MSPHERE 10 PLAT 10 3MMX5.4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	SPH10030020
Medical Device Problem Codes	Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient age, gender, weight, medical history, race, and ethnicity was not provided.Procode: krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).Initial reporter: the customer contact information was not reported.The product is available for evaluation and testing; however, it has not been received to date (which is indicated as "other").Additional information will be submitted within 30 days of receipt.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.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, the 3mm x 5.4cm micrusphere 10 (sph10030020/s10858) thermo-mechanical coil could not be advanced through the unspecified microcatheter.The coil was removed from the microcatheter and was noted to be stretched.The coil was replaced to complete the procedure.No patient complications occurred as a result of the event.The product will be returned for evaluation.No further information was provided.
Additional Manufacturer Narrative
(b)(4).As reported by a healthcare professional, during a coil embolization of an intracranial aneurysm, the 3mm x 5.4cm microsphere 10 (b)(4) thermo-mechanical coil could not be advanced through the unspecified microcatheter.The coil was removed from the microcatheter and was noted to be stretched.The coil was replaced.The same microcatheter was used to complete the case.No patient complications occurred as a result of the event.There was no report of a clinically significant delay in the procedure.The resistance was first noted by the user during advancement of the coil through the unspecified microcatheter.The coil delivery system was prepped without any difficulty.An adequate continuous flush was maintained through the microcatheter.No visible product damage was noted prior to the event.It was not reported if excessive force was applied during the case.It is unknown if the embolic coil was still attached to the delivery system when removed from the patient.No further information was provided.The microsphere 10 was returned without its original packaging.The device was returned sheathed as indicated by the length of the introducer proximal to the resheathing tool.The device was returned with the articulating joint advanced from the introducer.The embolic coil was noted to be detached from the device.The embolic coil was not returned with the complaint unit.The device positioning unit (dpu) core wire was seen protruding from the skive of the introducer distal to the resheathing tool.No kinks were observed along the dpu core wire.The device was inspected under a microscope.The distal outer sheath had not been softened, indicating that the resistance heating coil had not heated, and the detachment process had not been initiated.Based on this observation, the conclusion can be made that the embolic coil was mechanically detached from the delivery system.The v-notch of the resheathing tool was undamaged.The dpu core wire could be seen entering the distal end of the resheathing tool outside the introducer.A small piece of introducer appeared to have been ¿shaved¿ creating a loose curled flap connected on its outer face near the point of core wire protrusion from the introducer skive.The device was inserted through a lab rotating hemostatic valve (rhv) and cerenovus prowler select lp microcatheter.The complaint device was successfully advanced all the way through with no resistance.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 reported customer complaint of impeded in microcatheter and unraveled/stretched in microcatheter could not be confirmed.The embolic coil and the concomitant microcatheter were not returned with the complaint device.Without these units, a complete analysis of the reported failure cannot be performed, and the cause of the reported event cannot be determined.The device was seen with the distal outer sheath with its pre-detachment form; therefore, the embolic coil can be concluded to be mechanically detached.The event description indicates that it is unknown if the embolic coil was still attached to the delivery system when removed from the patient; therefore, the exact circumstances surrounding the mechanical detachment of the embolic coil cannot be determined based on the condition of the returned device.The remaining device was successfully advanced through a lab prowler select microcatheter.100% of devices are inspected in-process for damage to the embolic coil and introducer.Thus, it is unlikely that the device left the manufacturing facility with the reported damage.Impeded in microcatheter and damage to the embolic coil are known potential failures associated with the use of the device.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.The coil delivery system does not present any obvious indication of manufacturing defect or anomaly that could have contributed to the event as reported.Assignment of root cause for the event remains speculative and inconclusive, based on the information provided and the evidence presented by the sample article; however, it is possible that procedural and handling factors, including device manipulation and interaction with the concomitant microcatheter, may have contributed to the reported failure and mechanical detachment of the embolic coil.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Event: additional information received on 26-sep-2018 indicated that the resistance was first noted by the user during advancement of the coil through the unspecified microcatheter.The coil was removed and the same microcatheter was used to complete the case.The coil delivery system was prepped without any difficulty.An adequate continuous flush was maintained through the microcatheter.No visible product damage was noted prior to the event.It was not reported if there was a clinically significant delay in the procedure.It was also not reported if excessive force was applied during the case.The intended procedure was a coil embolization of an intracranial aneurysm.The concomitant microcatheter is not available for return.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.Initial reporter phone: (b)(6).The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: MSPHERE 10 PLAT 10 3MMX5.4CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7833438
• Report Number: 3008114965-2018-00731
• Device Sequence Number: 13742050
• Product Code: KRD
• UDI-Device Identifier: 00878528003526
• UDI-Public: 00878528003526
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002056
• 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): 08/15/2018

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: SPH10030020
• Device Lot Number: S10858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 09/18/2018; 11/07/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/03/2018; 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1