MAUDE Adverse Event Report: SEE H.10 MICRUSPHERE XL 5MMX14CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	SSR100514-20
Medical Device Problem Codes	Positioning Failure (1158); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The patient identifier is not known.The patient¿s age is not known.The patient's weight is not known.(b)(4).Concomitant med products: stryker, sl-10 microcatheter, detachment cable.The initial reporter phone and email are not available.(b)(4).The device has not been returned.If the device returns, a device investigation will be performed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the coil embolization procedure for an aneurysm at the middle cerebral artery, the physician deployed the micrusphere xl 5 mm x 14 cm (ssr10051420 / s14107) through a stryker sl-10 microcatheter.The coil formed a good basket inside the aneurysm.When the physician connected the detachment cable and pressed the button on the detachment control box, the coil did not detach.Several attempts were made but the coil failed to detach.The physician removed the coil and deployed another 5x14 micrusphere and the successfully detach the coil on the first attempt using the same detachment cable.There was no report of any patient injury or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).[additional information]: the healthcare professional reported that during the coil embolization procedure for an aneurysm at the middle cerebral artery, the physician deployed the micrusphere xl 5mm x 14cm (ssr10051420/s14107) through a stryker sl-10 microcatheter.The coil formed a good basket inside the aneurysm.When the physician connected the detachment cable and pressed the button on the detachment control box, the coil did not detach.Several attempts were made but the coil failed to detach.The physician removed the coil which was still attached to the delivery system.The physician deployed another coil, a micrusphere 5x14 using the same microcatheter and the successfully detach the coil on the first attempt using the same detachment cable.It was confirmed that the coil delivery system was prepped without any difficulty.There was no report of any patient injury or complication.The event did not result in any significant delay in the procedure.Product was received and is pending evaluation.The manufacturer will submit a supplemental report once evaluation is completed.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.
Additional Manufacturer Narrative
(b)(4).Product was received and is pending evaluation.The manufacturer will submit a supplemental report once evaluation is completed.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).[complaint conclusion]: the healthcare professional reported that during the coil embolization procedure for an aneurysm at the middle cerebral artery, the physician deployed the micrusphere xl 5mm x 14cm ((b)(4)/ (b)(4)) through a stryker sl-10 microcatheter.The coil formed a good basket inside the aneurysm.When the physician connected the detachment cable and pressed the button on the detachment control box, the coil did not detach.Several attempts were made but the coil failed to detach.The physician removed the coil which was still attached to the delivery system.The physician deployed another coil, a micrusphere 5x14 using the same microcatheter and the successfully detach the coil on the first attempt using the same detachment cable.It was confirmed that the coil delivery system was prepped without any difficulty.There was no report of any patient injury or complication.The event did not result in any significant delay in the procedure.Investigation summary: the device was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The embolic coil is located in the translucent introducer sheath.A section of device positioning unit (dpu) core wire protrudes from the skive of the translucent introducer sheath.The dpu core wire is bent approximately 17 cm and 61 cm from the proximal end.The green introducer is compressed.The ball tip is intact.There is blood on the embolic coil.The embolic coil is stretched.The articulating joint is intact.The condition of the resistance heating (rh) coil is obscured by the translucent introducer sheath.There is blood in the translucent introducer sheath at the point where the dpu core wire protrudes.The protrusion of the dpu core wire extends to the resheathing tool.The v-notch of the resheathing tool is fractured.An attempt was made to advance the embolic coil out of the introducer to visualize the rh coil.The embolic coil could not be advanced or retracted.The resistance of the device was measured with multimeter 70042-04d.Resistance measured 51.3 , which is within the specification range of 48.5 ¿ 56.0 per pic-cspec51457 rev.7.The device was connected to lab detachment control box dcb000005-00 (dcb) f79684 with enpower control cable c10702 and the power was turned on.The system ready light illuminated.Detachment cannot be attempted because the embolic coil cannot be advanced out of the introducer.A review of manufacturing documentation associated with this lot (s14107) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Investigation conclusion: the complaint of failure to detach is not confirmed.While the embolic coil is attached to the returned device, the resistance of the device tested within specification and the system ready light illuminated when it was connected to the dcb.Detachment could not be tested because of damage to the embolic coil and introducer that prevents the embolic coil from advancing out of the introducer.Because the embolic coil could not be advanced out of the introducer, the condition of the distal outer sheath over the rh coil could not be directly observed.Thus, it could not be determined whether the rh coil had heated.Heating of the rh coil would be indicative of a detachment cycle having been initiated.The compression of the green introducer, bends in the dpu core wire, and the stretched embolic coil are indicative of the application of excessive force to the device.The compression of the green introducer may have been due to over-tightening of the rotating hemostatic valve (rhv).The ifu (lcn (b)(4) rev.C) cautions against over-tightening the rhv around the introducer, as it may damage the introducer and/or the embolic coil.If the rhv was over-tightened, then it may have provided resistance to advancement and/or retraction of the embolic coil.Application of force during advancement would cause bending of the dpu core wire, and application of force during retraction could cause stretching of the embolic coil.The protrusion of the dpu core wire could have occurred as a result of application of excessive force while advancing the device, or it could have occurred during retraction and resheathing of the device.The v-notch fracture 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 or protrusion of the dpu core wire.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.

• Brand Name: MICRUSPHERE XL 5MMX14CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7394668
• Report Number: 2954740-2018-00506
• Device Sequence Number: 16226788
• Product Code: KRD
• UDI-Device Identifier: 00878528009931
• UDI-Public: (01)00878528009931(11)170511(17)220430(10)S14107
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/19/2018

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: 04/30/2022
• Device Model Number: SSR100514-20
• Device Catalogue Number: SSR10051420
• Device Lot Number: S14107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 03/19/2018; 03/19/2018; 03/19/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 05/01/2018; 05/17/2018; 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1