MAUDE Adverse Event Report: SEE H.10 DELTAFILL18 16MM X 50CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF181650
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.(b)(4).The initial reporter first name, phone and email address are unknown.[conclusion]: the healthcare professional reported that during the coil embolization procedure at the internal iliac artery (iia), the deltafill 18 16 mm x 50 cm coil (dlf181650 / s12208) was the 7th coil chosen; when the coil was removed from the package, it was noticed that the coil was had protruded from the sheath introducer.It was confirmed that excessive force was not used during the handling of the coil.The deltafill coil was replaced with another from a different lot number and the procedure was successfully completed without further issues or delay.There was no report of patient injury or complication; the complaint product was new and was stored per labeling instructions.The deltafill 18 coil was returned for evaluation; the prescore rupture reported was confirmed.In addition, the embolic coil was observed to be kinked where it passes into the coil introducer at the short, sheathed segment.This investigational finding meets fda reporting criteria.Investigation summary: the embolic coil was seen protruding through the skive of the translucent introducer sheath.A significant length of the embolic coil has protruded from the skive of the translucent introducer sheath in two segments.There was a kink in the device positioning unit (dpu) core wire approximately 61 cm from the proximal end.The device was returned with the distal ball tip about an inch from the distal end of the green introducer.The device is fully sheathed, as indicated by the position of the introducer lock inside the resheathing tool.The ball tip was observed to be intact within the green introducer.The embolic coil passes out through the skive of the translucent introducer sheath near its distal end.It is kinked where it passes into the introducer at the short, sheathed segment.The articulating joint is seen to be aligned.The v-notch in the resheathing tool is undamaged.A review of manufacturing documentation associated with this lot (s12208) 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 prescore rupture is confirmed.The device was returned with the embolic coil protruding from the skive in two segments.The cause of the rupture cannot be identified from the condition of the returned device.According to the event description, the embolic coil was observed to be protruding when the device was received, which is supported by the evidence that the device was returned fully sheathed, with the introducer lock in place in the resheathing tool.There is a kink in the dpu core wire of the returned device, indicating that excessive force was applied to the device.It cannot be determined from the condition of the returned device whether the force was applied while removing the device from the packaging hoop or after the protrusion of the embolic coil was observed.If force was applied to the device as it was being removed from the packaging hoop, it is possible that it could have resulted in the protrusion of the embolic coil.100% of devices are inspected for the condition of the embolic coil at final assembly per including advancing the coil out of the introducer and retracting it back in.In addition, 100% of devices are inspected for damage to the introducer at final quality control (qc) inspection.Thus, it is unlikely that the device left the manufacturing facility with the observed damage or with the embolic coil protruding from the skive of the translucent introducer sheath.Device history lot - a review of manufacturing documentation associated with this lot (s12208) 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.With the information provided in the complaint and the returned device with the embolic coil protruding from the skive in two segments, the prescore rupture initially reported was confirmed, though its cause was not identified.The embolic coil was kinked at the location where it passes into the introducer at the short, sheathed segment.There is also a kink in the dpu wire which suggests that excessive force was applied to the device; the condition of the returned device did not provide the means to determine whether the force applied during the removal of the device from the packaging hoop or after the coil protrusion from the sheath introducer was noticed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the observed kinked in the embolic coil could not be conclusively determined.If force was applied to the device as it was being removed from the packaging hoop, it is possible that it could have resulted in the protrusion of the embolic coil.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 at the internal iliac artery (iia), the deltafill 18 16 mm x 50 cm coil (dlf181650 / s12208) was the 7th coil chosen; when the coil was removed from the package, it was noticed that the coil was had protruded from the sheath introducer.It was confirmed that excessive force was not used during the handling of the coil.The deltafill coil was replaced with another from a different lot number and the procedure was successfully completed without further issues or delay.There was no report of patient injury or complication; the complaint product was new and was stored per labeling instructions.The deltafill 18 coil was returned for evaluation; the prescore rupture reported was confirmed.In addition, the embolic coil was observed to be kinked where it passes into the coil introducer at the short, sheathed segment.This investigational finding meets fda reporting criteria.

• Brand Name: DELTAFILL18 16MM X 50CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7786897
• Report Number: 3008114965-2018-00709
• Device Sequence Number: 2217889
• Product Code: KRD
• UDI-Device Identifier: 10886704077145
• UDI-Public: 10886704077145
• 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): 05/23/2018

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: 09/30/2019
• Device Catalogue Number: DLF181650
• Device Lot Number: S12208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1