MAUDE Adverse Event Report: REFER TO SECTION H10 DELTAXSFT10 2MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLX100206
Medical Device Problem Codes	Stretched (1601); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Based on the embolic coil damage noted during product investigation, this event meets the required criteria for mdr reporting.Information regarding patient age, gender, weight, medical history, race, and ethnicity was not provided.Procode: krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)) concomitant medical products due to character limitation: prowler select lpes microcatheter, enpower dcb2 detachment control box, enpower control cable complaint conclusion: as reported by a healthcare professional, during a coil embolization of a gastrointestinal hemorrhage (two branches), the 2mm x 6cm deltaxsft10 (dlx100206/s13030) thermo-mechanical coil was selected for use as the last coil but the coil became stuck in the prowler select lpes (unk catalog & lot) microcatheter.The physician felt that the aneurysm was successfully treated without need for additional coiling.No patient complications occurred as a result of the event.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.In the one of the two lesions, two coils (deltafill10 & micrusframec) were placed in the lesion without incident.In this lesion, a micrusframec coil was utilized as the first coil.No visible product damage was noted prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.An enpower dcb2 detachment control box and enpower control cable were also used for the case.The sales representative advised the user to flush the microcatheter before use.No further information was provided.The deltaxsft10 was returned for investigation.The device positioning unit (dpu) core wire was seen protruded through the skive of the translucent introducer sheath.The resheathing tool was broken in two pieces.The device was almost fully sheathed, as indicated by the length of the introducer proximal of the resheathing tool.The device was returned with the embolic coil inside the translucent introducer sheath.Blood was seen in the introducer.No kinks were observed on the dpu core wire.Ball tip of the embolic coil was obscured by blood.Damage was observed at the distal end of the embolic coil just proximal to the ball tip.Kinks were observed in the embolic coil.Significant damage was observed at the proximal end of the embolic coil.At this location, the embolic coil was kinked, stretched, and folded over on itself.The articulating joint was damaged, as it was observed to be pressed against the proximal end of the embolic coil.The dpu core wire was not enclosed in the translucent introducer sheath as they passed into the distal end of the resheathing tool.The dpu core wire was seen entering the translucent introducer sheath at a more proximal point in the skive.No damage was observed to the v-notch of the resheathing tool.After the length of the embolic coil was measured, the skive of the translucent introducer sheath was opened to visualize the embolic coil ball tip.The ball tip was present and intact and was covered in dried blood.An attempt was made to advance the embolic coil out of the introducer.The embolic coil could not be advanced out of the introducer.There was significant resistance attempting to advance the device.When the dpu core wire was advanced, the dpu core wire side of the articulating joint advanced within the introducer.However, the embolic coil was stuck in the introducer, and its movement was impeded at its proximal end.The length of the embolic coil was measured using ruler.The embolic coil measured approximately 7 centimeters (cm).A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint of ¿detachable coil delivery system (dcs) - impeded in microcatheter with no loss of cerebral target position¿ was confirmed.Because of the damage to the embolic coil, the device could not be advanced out of its introducer.The articulating joint was observed to be compressed and the proximal end of the embolic coil was found to be kinked, stretched, and folded over on itself.In addition, the embolic coil was observed to be kinked or damaged in three other locations.This damage to the embolic coil and the articulating joint is likely to be the result of application of excessive force to the device while attempting to advance the embolic coil in the presence of resistance.Resistance may have been present due to insufficient flush.The presence of blood in the translucent introducer sheath and covering the embolic coil ball tip suggests that an insufficient flush was maintained.The ifu states that continuous infusion of an appropriate flush solution is required for optimal performance and 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.Additional resistance may have been provided by the operational context and/or the microcatheter.The prowler select microcatheter used during the procedure was not returned.Without the return of this device, it is not possible to conclusively identify all causes of resistance.100% of devices are inspected for damage to the embolic coil, including advancing the embolic coil out of the introducer and retracting it back in.Thus, it is very unlikely that the device left the manufacturing facility with the observed damage to the embolic coil.Impeded in microcatheter is a known potential issue associated with the use of the device.The ifu contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.With review of the analysis and the device history records, there is no indication of any manufacturing issues related to the reported event or damages noted on the returned system.Although a definitive conclusion cannot be made, it is possible that circumstances of the procedure, including device manipulation/interaction and insufficient flush, may have contributed to the event and damages observed on the returned device.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.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization of a gastrointestinal hemorrhage (two branches), the 2mm x 6cm deltaxsft10 (dlx100206/s13030) thermo-mechanical coil was selected for use as the last coil but the coil became stuck in the prowler select lpes (unk catalog & lot) microcatheter.The physician felt that the aneurysm was successfully treated without need for additional coiling.No patient complications occurred as a result of the event.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.In the one of the two lesions, two coils (deltafill10 & micrusframec) were placed in the lesion without incident.In this lesion, a micrusframec coil was utilized as the first coil.No visible product damage was noted prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.An enpower dcb2 detachment control box and enpower control cable were also used for the case.The sales representative advised the user to flush the microcatheter before use.No further information was provided.

• Brand Name: DELTAXSFT10 2MM X 6CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7851623
• Report Number: 3008114965-2018-00733
• Device Sequence Number: 11385073
• Product Code: KRD
• UDI-Device Identifier: 10886704077336
• UDI-Public: 10886704077336
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

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: 11/30/2019
• Device Catalogue Number: DLX100206
• Device Lot Number: S13030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1