MAUDE Adverse Event Report: SEE H.10 MICRUSPHERE XL 8MMX25CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	SSR10082520
Medical Device Problem Code	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).[conclusion]: the healthcare professional reported that the micrusphere xl 10 stretch resistant coil 8 mm x 25 cm (ssr10082520 / c19812) could not be advanced in the introducer.Additional information related to the target vessel was not available.The coil was not used as it did not slide correctly through the introducer.There was no report of patient injury or adverse event.Investigation summary: there is a bend at the distal end of the green introducer.There is blood in the translucent introducer sheath.The embolic coil is in the translucent introducer sheath, proximal to the observed blood.The device is almost fully sheathed.There is a bend in the device positioning unit (dpu) core wire approximately 132 cm from the proximal end.The distal end of the green introducer is kinked.Blood blocks the translucent introducer sheath.The ball tip is present and intact.There is blood on the embolic coil.The embolic coil is kinked.The condition of the articulating joint and resistance heating (rh) coil are obscured by the translucent introducer sheath.The v-notch of the resheathing tool is fractured.An attempt was made to advance the embolic coil out of the introducer and unsheathe the dpu.Damage to the embolic coil prevented it from being advanced out of the introducer.A review of manufacturing documentation associated with this lot (c19812) 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 impeded is confirmed.Kinks in the embolic coil prevents the embolic coil from advancing through the introducer.Kinking may occur when excessive force is applied when advancing the device in the presence of resistance.In this case, resistance may have been provided by insufficient flush.The presence of blood blocking 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.In addition, the kinks observed in the distal end of the green introducer may have contributed to resistance.Kinks in the introducer cause narrowing of the lumen, which will then cause friction as the embolic coil passes through.The cause of the kinks in the introducer is not apparent from the condition of the returned device.However, 100% of devices are inspected for damage to the introducer at quality control (qc) final inspection per pic-cspec51457 rev.8.Finally, the v-notch of the resheathing tool is fractured.The damage to the resheathing tool indicates that the device was not properly unlocked.The ifu instructs the user to unlock the device by gently pulling the clear tab of the introducer sheath out and away from the re-sheathing tool at a 45-degree angle.Pulling the tab straight out (in parallel to the dpu) will result in damage to the resheathing tool and may cause damage to the embolic coil.Device history lot - a review of manufacturing documentation associated with this (c19812) 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.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 10 stretch resistant coil 8 mm x 25 cm (ssr10082520 / c19812) could not be advanced in the introducer.Additional information related to the target vessel was not available.The coil was not used as it did not slide correctly through the introducer.There was no report of patient injury or adverse event.

• Brand Name: MICRUSPHERE XL 8MMX25CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7735460
• Report Number: 3008114965-2018-00697
• Device Sequence Number: 13707814
• Product Code: KRD
• UDI-Device Identifier: 00878528009962
• UDI-Public: 00878528009962
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K032872
• 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): 05/04/2018

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: 07/31/2018
• Device Catalogue Number: SSR10082520
• Device Lot Number: C19812
• 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: 07/30/2018
• 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