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

Catalog Number	DLX100206
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Based on the significant embolic coil damage noted during the product investigation, the event meets the 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: super sheath (boston scientific) sheath introducer.0.014" 200cm chikai black (asahi intecc) guidewire.6f shuttle sheath (cook) guiding catheter.Excelsior xt-17 (stryker) microcatheter.Enpower dcb2 detachment control box.(b)(6).[complaint conclusion]: as reported by a healthcare professional, during a coil embolization of a carotid-cavernous fistula (ccf) at the superior ophthalmic vein (sov) and cavernous sinus (cs), the sheath introducer of the 2mm x 6cm deltaxsft10 (dlx100206/s13813) thermo-mechanical coil was inserted into the concomitant y-connector and they were flushed; however, while the coil was being advanced into the excelsior xt-17 (stryker) microcatheter, the coil became stuck and would not exit the introducer.The coil was replaced with a coil from the same lot, but the same issue occurred.Therefore, the coil was replaced.The procedure was completed successfully without further incident.No patient complications occurred as a result of the event.The procedure was not delayed due to 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.No visible product damage was noted prior to and after the event.A super sheath (boston scientific) sheath introducer, 0.014¿ 200cm chikai black (asahi intecc) guidewire, 6f shuttle sheath (cook) guiding catheter, and an enpower dcb2 detachment control box were also used for the case.No further information was provided.Two devices with the same catalog number and lot number were returned in the same package for this complaint.Both devices on the complaint were reported to have the same issue.Since the two devices cannot be distinguished, they were arbitrarily assigned to the two product investigations and were evaluated separately.Device b: the embolic coil could be seen in the translucent introducer.Blood was seen in the green and translucent areas of the introducer.The resheathing tool was seen broken in two segments.The device positioning unit (dpu) core wire was kinked approximately 100 cm from the proximal end of the device.The distal ball tip of the embolic coil was present and intact as seen microscopically.The embolic coil was kinked in the middle of its length and near its proximal end.The socket ring appeared to be pressed into the pet sheath.Blood was seen in the introducer and on the dpu core wire.The resheathing tool was seen broken in two segments.The v-notch of the resheathing tool was undamaged.When attempting to advance the device, the coil compressed into itself and against the inner walls of the introducer.During the review of the manufacturing documentation, it was noted that 4 units were rejected.However, the device history record review confirmed that all product rejected during manufacturing was identified as scrap and properly accounted for.No other issues were noted that were considered potentially related to the reported complaint.The reported customer complaint of impeded in introducer was confirmed.The device could not be advanced out of the introducer due to friction caused from motion of the embolic coil towards the inner walls of the introducer.This angled path of motion was a result of kinks in the embolic coil.The exact circumstances surrounding the observed damage to the coil cannot be determined based on the condition of the returned device; however, it is possible that the damage occurred during insertion into the delivery system.The damage seen to the embolic coil, resheathing tool, and dpu core wire may have been a result of excessive force applied when attempting to advance and retract the device in the event of resistance.Impeded in introducer 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.The blood observed in the introducer suggests that an insufficient flush was maintained.The 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.100% of devices are inspected for damage to the embolic coil.100% of devices are also tested for proper movement of the dpu core wire and embolic coil in the introducer.Thus, it is unlikely that the device left the manufacturing facility with the observed issues.Neither the product analysis nor the device history record review suggests that the failure could be related to the manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the information provided and the evidence presented by the returned device; however, it is possible that procedural and handling factors, including device manipulation, device interaction, and insufficient flush, may have contributed to the reported failure and damages noted on 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.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 3008114965-2018-00771.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization of a carotid-cavernous fistula (ccf) at the superior ophthalmic vein (sov) and cavernous sinus (cs), the sheath introducer of the 2mm x 6cm deltaxsft10 (dlx100206/s13813) thermo-mechanical coil was inserted into the concomitant y-connector and they were flushed; however, while the coil was being advanced into the excelsior xt-17 (stryker) microcatheter, the coil became stuck and would not exit the introducer.The coil was replaced with a coil from the same lot, but the same issue occurred.Therefore, the coil was replaced.The procedure was completed successfully without further incident.No patient complications occurred as a result of the event.The procedure was not delayed due to 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.No visible product damage was noted prior to and after the event.A super sheath (boston scientific) sheath introducer, 0.014¿ 200cm chikai black (asahi intecc) guidewire, 6f shuttle sheath (cook) guiding catheter, and an enpower dcb2 detachment control box were also used for the case.Evaluation of the returned products revealed embolic coil damage.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: 7982516
• Report Number: 3008114965-2018-00772
• Device Sequence Number: 1396132
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/20/2018

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: 03/31/2020
• Device Catalogue Number: DLX100206
• Device Lot Number: S13813
• 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: 10/17/2018
• Initial Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1