MAUDE Adverse Event Report: SEE H.10 MICRUSPHERE XL 18MMX40CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	SSR18184020
Medical Device Problem Codes	Stretched (1601); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient age, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.(b)(4).Initial reporter information such as the name and phone are unknown.[complaint conclusion]: the healthcare professional reported that the micrusphere xl 18 stretch resistant coil 18 mm x 40 cm (ssr18184020 / s12635) was defective.Additional information related to the target vessel and the details regarding the defective coil was not available.There was no report of patient injury or adverse event.Investigation summary: the embolic coil is located in the translucent introducer sheath.There is blood in the translucent introducer sheath.The device is almost fully sheathed.There is a kink in the device positioning unit (dpu) core wire approximately 132 cm from the proximal end, just proximal to the resheathing tool.The ball tip is present and intact.There is blood on the embolic coil.The embolic coil is kinked and stretched.The condition of the articulating joint and resistance heating (rh) coil are obscured by the translucent introducer sheath.There is minor plastic remodeling damage to the v-notch of the resheathing tool.An attempt was made to advance the embolic coil out of the introducer.Damage to the embolic coil prevents the embolic coil from advancing.A review of manufacturing documentation associated with this lot (s12635) 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.Investigation conclusion: the complaint that the device is damaged is confirmed.The embolic coil is kinked and stretched.Stretching generally occurs when excessive retraction force is applied to the device in the presence of resistance.Kinking can occur when excessive advancement force is applied to the device in the presence of resistance.The kink observed in the dpu core wire is also indicative of the application of excessive force to the device.Resistance may have been present due to insufficient flush.The presence of blood in the translucent introducer sheath and on the embolic coil suggests that an insufficient flush was maintained.The ifu (lcn 51844-001 rev.C) 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.One-hundred percent (100%) of devices are inspected at final assembly for the condition of the embolic coil, including advancing the coil out of the introducer and retracting it back, per mps-prp0246 rev.9.Thus, it is unlikely that the device left the manufacturing facility with the observed damage to the embolic coil.Device history lot - a review of manufacturing documentation associated with this lot (s12635) 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.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 information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that the micrusphere xl 18 stretch resistant coil 18 mm x 40 cm (ssr18184020 / s12635) was defective.Additional information related to the target vessel and the details regarding the defective coil was not available.There was no report of patient injury or adverse event.

• Brand Name: MICRUSPHERE XL 18MMX40CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7736588
• Report Number: 3008114965-2018-00698
• Device Sequence Number: 13683198
• Product Code: KRD
• UDI-Device Identifier: 00878528009993
• UDI-Public: 00878528009993
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2018

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: 10/31/2021
• Device Catalogue Number: SSR18184020
• Device Lot Number: S12635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1