MAUDE Adverse Event Report: REFER TO SECTION H10 MSPHERE 10 PLAT 5MMX9.7CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	SPH10050020
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Based on the embolic coil damage noted during the product investigation, this event meets the required criteria for mdr reporting.Information regarding patient weight, medical history, race, and ethnicity was not provided.Procode: krd/hcg.(b)(4).Concomitant med products due to character limitation: 6f short sheath, 6f 90cm envoy guiding catheter, echelon-10 (medtronic) microcatheter, x-pedion 14 (medtronic) guidewire initial reporter occupation: scrub tech.(b)(4).[complaint conclusion] as reported by a healthcare professional, during a coil embolization of a 5mm unruptured moderately tortuous right anterior communicating artery aneurysm, the 5mm x 9.7cm micrusphere 10 (sph10050020/p10782) thermo-mechanical coil was advanced to the aneurysm as the first coil in the case, and positioned several times but the physician was unable to get the coil in the correct position.The physician stated that the last two loops of the coil did not form correctly.The coil was removed from the patient without issue and replaced with a 4mm x 7.5cm micrusphere 10 (sph10040020/p10914) but the same issue occurred after positioning the coil several times.The physician again felt that the last two loops were not forming like the coil typically does.The physician stated that he usually achieves a nice structure, but the loops did not behave like he was used to with the micrusphere.He described the coils as defective but did not report any damage/stretched condition.The procedure was completed without incident or delay using competitor coils.No patient complications occurred as a result of the event.The patient did well post-operatively and was discharged the following day.Approach was made via the right femoral artery with a 6f short sheath.A 6f 90cm envoy guiding catheter, echelon-10 (medtronic) microcatheter, and x-pedion 14 (medtronic) guidewire were also used for the case.The products were stored, prepped, and handled according to the instructions for use (ifu).The concomitant echelon-10 microcatheter was discarded and is thus not available for return.No further information was provided.The 5mm x 9.7cm micrusphere 10 was returned for evaluation.The label that was returned with the product matched the complaint information.The device was returned unsheathed as indicated by the length of the introducer sheath proximal of the resheathing tool.The embolic coil was returned advanced out of the introducer and was seen stretched.The embolic coil could not form its coil shape properly because it was stretched.No kinks were observed in the device positioning unit (dpu) core wire.The ball tip of the embolic coil was present and intact.The embolic coil was seen stretched under the microscope.No other damage was found on the embolic coil.The distal outer sheath was not softened, indicating that the rh coil had not heated and there was no attempt to detach the coil.The articulating joint was slightly damaged.A bend in the marker band was observed.The v-notch of the resheathing tool was seen undamaged.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.No product in this lot was rejected during manufacturing.The complaint 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 embolic coil may make it more difficult to achieve correct positioning.The coil was stretched and unable to re-form its shape properly.While the sequence of events leading to the observed damage to the coil cannot be determined based on the condition of the returned device, stretching 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.The device does not present any obvious indication of manufacturing defect or anomaly that could have contributed to the event as reported.Positioning difficulty and coil stretching are known potential issues associated with the use of the device.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 clinical and procedural factors, including device selection, vessel characteristics, and device manipulation, may have contributed to the reported failure.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.This is one of two products involved with the reported complaint and the associated manufacturer report numbers are 3008114965-2018-00748 & 3008114965-2018-00749.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization of a 5mm unruptured moderately tortuous right anterior communicating artery aneurysm, the 5mm x 9.7cm micrusphere 10 (sph10050020/p10782) thermo-mechanical coil was advanced to the aneurysm as the first coil in the case, and positioned several times but the physician was unable to get the coil in the correct position.The physician stated that the last two loops of the coil did not form correctly.The coil was removed from the patient without issue and replaced with a 4mm x 7.5cm micrusphere 10 (sph10040020/p10914) but the same issue occurred after positioning the coil several times.The physician again felt that the last two loops were not forming like the coil typically does.The physician stated that he usually achieves a nice structure, but the loops did not behave like he was used to with the micrusphere.He described the coils as defective but did not report any damage/stretched condition.The procedure was completed without incident or delay using competitor coils.No patient complications occurred as a result of the event.The patient did well post-operatively and was discharged the following day.Approach was made via the right femoral artery with a 6f short sheath.A 6f 90cm envoy guiding catheter, echelon-10 (medtronic) microcatheter, and x-pedion 14 (medtronic) guidewire were also used for the case.The products were stored, prepped, and handled according to the instructions for use (ifu).Investigation of the returned products revealed embolic coil damage.The concomitant echelon-10 microcatheter was discarded and is thus not available for return.No further information was provided.

• Brand Name: MSPHERE 10 PLAT 5MMX9.7CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7904057
• Report Number: 3008114965-2018-00748
• Device Sequence Number: 169773
• Product Code: KRD
• UDI-Device Identifier: 00878528003557
• UDI-Public: 00878528003557
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K002056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2018

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: SPH10050020
• Device Lot Number: P10782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR