MAUDE Adverse Event Report: SEE H.10 DELTAPLUSH COIL, 10 SYS 2X3; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DPL10020320
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).[conclusion]: the healthcare professional reported that during the coil embolization procedure with the target vessel at the internal carotid artery (ica) on a (b)(6) patient with a history of head trauma and whose vessel was reported to be very tortuous, the deltaplush 10 2mm x 3cm coil (dpl10020320 / s14053) was reported to have advancing issue.The coil could not advance through the microcatheter (stryker, sl-10).There was no damage to the coil or coil detachment system prior to the procedure.It was reported that the coil could not be pushed into the microcatheter with ease, that it seems stuck.The device was prepped in accordance with the instruction for use (ifu), adequate continuous flush was maintained through the catheter at all times.There was no report of any clinical delay to the procedure due to the reported issue.There was no report of patient consequence or adverse event related to the reported issue.The device was returned for evaluation.The investigation finding is documented below.Investigation summary: the device was returned almost completely sheathed as indicated by the length of the introducer proximal to the resheathing tool.The resheathing tool can be seen broken into two pieces.Blood can be seen in the green introducer.The distal end of the dpu core wire, articulating joint, and proximal end of the embolic coil are seen protruding from the translucent part of the introducer.The device positioning unit (dpu) core wire is kinked at approximately 5 cm, 26 cm, 34 cm, 50 cm, 91 cm, 110 cm, and 137 cm from the proximal end of the device.The green introducer is seen with blood inside.The embolic coil distal ball tip is present and intact.The distal end of the dpu core wire is seen protruding from the introducer.The embolic coil is seen kinked where it re-enters the introducer.The damaged proximal end of the embolic coil is seen.The articulating joint is also damaged/bent.Kinks are seen within the embolic coil.The resheathing tool is seen broken in two pieces.The v-notch of the resheathing tool is undamaged.The device cannot be advanced due to the damaged condition of the introducer, dpu core wire and embolic coil.Therefore, advancement through a microcatheter cannot be achieved.A review of manufacturing documentation associated with this lot (s14053) 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 of detachable coil delivery system (dcs) impeded in microcatheter with no loss of cerebral target position is confirmed.The device cannot be advanced because of the protrusion of the dpu core wire and embolic coil from the introducer and damage to the articulating joint and embolic coil.The presence of blood in the introducer suggests that an insufficient flush was maintained.The instruction for use (ifu) 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.It is possible that the operator met resistance and used excessive force in order to advance the device which caused the dpu core wire and embolic coil to pop out from the introducer as well as damage the dpu core wire in multiple locations.The complaint description does not indicate when the issue was first observed by the physician.It is also possible that the resheathing tool was advanced over the tip coil of the dpu while unsheathing the device.The ifu instructs the user to unsheathe a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the resheathing tool.This results in the placement of the embolic coil and the more flexible and fragile distal sections of the dpu inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing into the microcatheter, there is a risk that the embolic coil or the distal end of the dpu will be unsheathed and pass through the resheathing tool.If the resheathing tool passes over the distal end of the dpu, this will expose these flexible sections, which will then be subject to kinking and bending.Once a part of the dpu is kinked or bent, the translucent introducer sheath will not be able to re-form around it, and that section of the device will protrude.100% of devices are inspected during manufacturing for damage to the embolic coil.It is unlikely that the device left the manufacturing facility with the observed damage to the embolic coil.100% of devices are inspected in-process for the ability to advance through the introducer and retract back.100% of devices are also inspected for sheathing functionality.Therefore, it is unlikely that the device left the manufacturing facility with the observed to the resheathing tool and introducer.The reported issue that the deltaplush 10 2mm x 3cm coil (dpl10020320 / s14053) could not advance through the microcatheter was confirmed with evaluation of the returned device.The coil could not advance because of the protrusion of the dpu core wire and embolic coil from the introducer and damage to the articulating joint and embolic coil.Although it was reported that adequate continuous flush was maintained through the microcatheter, the presence of dried blood in the introducer suggests that the flush was not sufficiently maintained.It is possible that the operator met resistance and used excessive force in order to advance the device which caused the dpu core wire and embolic coil to pop out from the introducer as well as damage the dpu core wire in multiple locations.It is also possible that the resheathing tool was advanced over the tip coil of the dpu while unsheathing the device.The ifu instructs the user to unsheathe a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the resheathing tool.This results in the placement of the embolic coil and the more flexible and fragile distal sections of the dpu inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing into the microcatheter, there is a risk that the embolic coil or the distal end of the dpu will be unsheathed and pass through the resheathing tool.If the resheathing tool passes over the distal end of the dpu, this will expose these flexible sections, which will then be subject to kinking and bending.Once a part of the dpu is kinked or bent, the translucent introducer sheath will not be able to re-form around it, and that section of the device will protrude.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Devices undergo 100% inspection during manufacturing for damage to the embolic coil.It is unlikely that the device left the manufacturing facility with the observed damage to the embolic coil.Devices undergo 100% in-process inspection for the ability to advance through the introducer and retract back and for sheathing functionality.Therefore, it is unlikely that the device left the manufacturing facility with the observed to the resheathing tool and introducer.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 during the coil embolization procedure with the target vessel at the internal carotid artery (ica) on a (b)(6) patient with a history of head trauma and whose vessel was reported to be very tortuous, the deltaplush 10 2mm x 3cm coil (dpl10020320 / s14053) was reported to have advancing issue.The coil could not advance through the microcatheter (stryker, sl-10).There was no damage to the coil or coil detachment system prior to the procedure.It was reported that the coil could not be pushed into the microcatheter with ease, that it seems stuck.The device was prepped in accordance with the instruction for use (ifu), adequate continuous flush was maintained through the catheter at all times.There was no report of any clinical delay to the procedure due to the reported issue.There was no report of patient consequence or adverse event related to the reported issue.The device was returned for evaluation.

• Brand Name: DELTAPLUSH COIL, 10 SYS 2X3
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7904207
• Report Number: 3008114965-2018-00750
• Device Sequence Number: 13495213
• Product Code: KRD
• UDI-Device Identifier: 00878528008057
• UDI-Public: 00878528008057
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K083646
• 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): 06/26/2018

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: 06/30/2020
• Device Catalogue Number: DPL10020320
• Device Lot Number: S14053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2018
• 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