MAUDE Adverse Event Report: REFER TO SECTION H10 DELTAXSFT10 3MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLX100306
Medical Device Problem Codes	Off-Label Use (1494); Separation Failure (2547); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).Concomitant med products due to character limitation: excelsior 1018 (stryker) microcatheter, chikai (asahi intecc) guidewire, and enpower (dcb2) dcb2000500 detachment control box physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2018-00787 & 3008114965-2018-00788.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization of a bronchial-intercostal artery, the fifth spectra coil failed to detach in the target lesion.Several attempts were made to detach the coil without success; therefore, the enpower control cable (ecb000182-00/s14572) was replaced and the coil was detached successfully.The 3mm x 12cm deltafill18 (dlf180312/s14732) thermo-mechanical coil was then connected to the control cable, but the power lamp did not illuminate.The coil was replaced.Two additional spectra coils were placed.The 3mm x 6cm deltaxtrasoft (dlx100306/s14197) thermo-mechanical coil was then inserted into the patient, but the coil failed to be detached despite multiple attempts.The power lamp was on and the control cable was new.The coil was replaced with a same-sized coil and the procedure was completed successfully without further incident.There was no report of patient injury.The surgery was not delayed due to the event.The products were new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and an adequate continuous flush was maintained through the microcatheter.The coil delivery systems were prepped and used according to the ifu.No visible product defect/damage was noted prior to the event.The connecting cable did not appear damaged.There was no report of a "fault" light on the detachment control box.No unintended detachment was observed in the vessel or in the microcatheter.The coils were successfully removed from the patient without need for additional intervention.The embolic coils were still attached to the delivery system when removed.An excelsior 1018 (stryker) microcatheter, chikai (asahi intecc) guidewire, and an enpower dcb2000500 detachment control box were also used in the case.The complaint coils will be returned for evaluation.The complaint cable is not available for evaluation.No further information was provided.
Additional Manufacturer Narrative
(b)(4).Complaint conclusion: as reported by a healthcare professional, during a coil embolization of a bronchial-intercostal artery, the fifth spectra coil failed to detach in the target lesion.Several attempts were made to detach the coil without success; therefore, the enpower control cable (b)(4) was replaced and the coil was detached successfully.The 3mm x 12cm deltafill18 (b)(4) thermo-mechanical coil was then connected to the control cable, but the power lamp did not illuminate.The coil was replaced.Two additional spectra coils were placed.The 3mm x 6cm deltaxtrasoft (b)(4) thermo-mechanical coil was then inserted into the patient, but the coil failed to be detached despite multiple attempts.The power lamp was on and the control cable was new.The coil was replaced with a same-sized coil and the procedure was completed successfully without further incident.No patient complications occurred as a result of the event.The coils were successfully removed from the patient without need for additional intervention.The embolic coils were still attached to the delivery system when removed.The surgery was not delayed due to the event.The devices were new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and an adequate continuous flush was maintained through the microcatheter.The coil delivery systems were prepped and used according to the ifu.No visible product defect/damage was noted prior to the event.The connecting cable did not appear damaged.There was no report of a "fault" light on the detachment control box.No unintended detachment was observed in the vessel or in the microcatheter.An excelsior 1018 (stryker) microcatheter, chikai (asahi intecc) guidewire, and an enpower (b)(4) detachment control box were also used in the case.No further information could be obtained.The 3mm x 6cm deltaxtrasoft was returned for evaluation.The returned label matched the complaint information.The device was returned unsheathed so that the proximal section of the green introducer was positioned within resheathing tool.Kinks were observed on the device positioning unit (dpu) core wire approximately 28 cm and 29 cm from the proximal end of the device.The device was returned with the embolic coil advanced from the introducer sheath.The coil and the distal flexible section of the dpu core wire were seen kinked.The device was then inspected under a microscope.The embolic coil distal ball tip was present and intact.The embolic coil was seen kinked at multiple places along its length.The proximal end of the embolic coil was seen pressed into the distal end of the distal outer sheath, damaging the articulating joint.The distal outer sheath had not been softened, indicating that the detachment process had not been initiated.The flexible distal end of the dpu core wire was seen kinked.The v-notch of the resheathing tool was seen with a fracture running down its middle.The resistance of the device was measured with lab multimeter and results were found within specification.The device was connected to lab equipment enpower detachment control box (b)(4) and enpower control cable c10702.The power was turned on and the system ready light steadily illuminated.The embolic coil and articulating joint were submerged in a heated enzyme solution and the detachment button on the dcb was pressed.The embolic coil was successfully detached.A review of manufacturing documentation associated with this 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.The reported customer complaint of failure to detach was not confirmed during functional analysis.The embolic coil was able to be successfully detached using the lab detachment control box and control cable.The control cable and dcb used in the procedure were not returned for analysis; therefore, a complete failure investigation could not be performed.Without the return of the concomitant dcb and control cable, the cause of the reported event cannot be conclusively determined.The embolic coil was pressed into the distal outer sheath and the dpu core wire was also kinked, indicating excessive force was likely applied to the device.In addition, the device was improperly unlocked as indicated by the fracture in the resheathing tool.Failure to follow the ifu in unlocking and unsheathing the device may damage the introducer or embolic coil.100% of embolic coils and core wires are inspected in-process.Thus, it is unlikely that the device left the manufacturing facility with the observed damages.Failure to detach is a known potential product failure 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.Per the ifu: ¿verify that the microcoil delivery system is fully connected and no faults are indicted on the dcb.If a fault exists, reseat all connections between the dpu, the dcb, and the connecting cable.If a fault still persists, replace the connecting cable.If this does not correct the error, replace the dcb.If the microcoil delivery system still continues to have a fault, retrieve the microcoil as described in the following section, re sheathing the microcoil system, and replace with a new microcoil system.¿ neither the product analysis nor the device history review suggests that the failure could be related to the manufacturing process of the unit.Assignment of root cause for the event remains speculative and inconclusive, based on the minimal information provided and evidence presented by the returned sample; however, it is possible that procedural and handling factors, including device manipulation, may have contributed to the reported failure to detach and damages noted to the returned system.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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2018-00787 & 3008114965-2018-00788.

• Brand Name: DELTAXSFT10 3MM X 6CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8033464
• Report Number: 3008114965-2018-00788
• Device Sequence Number: 1380043
• Product Code: KRD
• UDI-Device Identifier: 10886704077350
• UDI-Public: 10886704077350
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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: DLX100306
• Device Lot Number: S14197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1