MAUDE Adverse Event Report: SEE H.10 DELTAFILL18 14MM X 45CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF181445
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.(b)(4).Concomitant med products: sheath introducer (medikit), guidewire (chikai, asahi intecc), guide catheter (parent45, medikit), microcatheter (sl-10, stryker), balloon catheter (scepter xc, terumo), y-connector (terumo), coils: target xxl, stryker, deltafill, enpower control cable, and detachment control box dcb2.Initial reporter information such as the name, phone and email address are unknown.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report, product was received and is pending evaluation.The manufacturer will submit a supplemental report once evaluation is completed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the coil embolization procedure targeting an aneurysm at the renal artery, the balloon catheter and the microcatheter were inserted into the guide catheter; the three devices were inserted from the left femoral artery (fa) to approach the target site as a unit.After the herniation was performed with the balloon catheter, the coil embolization procedure began.The first coil was selected, a stryker target xxl 22 mm coil was placed followed by 4 other coils placed.Three deltafill 20 mm coils were placed and the piolax c-stopper coil was used as the filling coil.The deltafill18 14 mm x 45 cm coil (dlf181445 / s13314) was the coil selected for placement near the aneurysm neck.The deltafill18 coil was inserted into the microcatheter (stryker, sl-10) but the coil encountered resistance.When the physician attempted to withdraw the coil, it became unraveled in the microcatheter.The deltafill18 coil was removed along with the microcatheter.The deltafill18 coil was replaced with another coil (target xxl).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 procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event; no unintended detachment was observed in the vessel or in the microcatheter.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).[conclusion]: the healthcare professional reported that during the coil embolization procedure targeting an aneurysm at the renal artery, the balloon catheter and the microcatheter were inserted into the guide catheter; the three devices were inserted from the left femoral artery (fa) to approach the target site as a unit.After the herniation was performed with the balloon catheter, the coil embolization procedure began.The first coil was selected, a stryker target xxl 22mm coil was placed followed by 4 other coils placed.Three deltafill 20mm coils were placed and the piolax c-stopper coil was used as the filling coil.The deltafill18 14 mm x 45 cm coil (dlf181445 / s13314) was the coil selected for placement near the aneurysm neck.The deltafill18 coil was inserted into the microcatheter (stryker, sl-10) but the coil encountered resistance.When the physician attempted to withdraw the coil, it became unraveled in the microcatheter.The deltafill18 coil was removed along with the microcatheter.The deltafill18 coil was replaced with another coil (target xxl).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 procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event; no unintended detachment was observed in the vessel or in the microcatheter.The product was returned for investigation; the investigational findings are documented below.Investigation summary: device returned as is, including a non-cerenovus microcatheter and a rotating hemostatic valve (rhv).The device was returned still inside the rhv and microcatheter.The device positioning unit (dpu) core wire is protruding from the skive of the translucent introducer sheath distal to the resheathing.The device is mostly unsheathed.An attempt was made to remove the embolic coil from the microcatheter.Device could not be taken out of the rhv and microcatheter due to the embolic coil being anchored at an unknown distance inside the catheter.The embolic coil could also not be advanced through the microcatheter.V-notch of the resheathing tool is undamaged.The embolic coil cannot be evaluated because it is anchored in the microcatheter.The embolic coil is anchored in the microcatheter and cannot be advanced or retracted.A review of manufacturing documentation associated with this lot (s13314) 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 that the embolic coil is unraveled or stretched cannot be confirmed.The embolic coil is anchored in the microcatheter and is unavailable for visual or microscopic analysis.The complaint that the device experienced resistance or friction during advancement is confirmed.The embolic coil is firmly anchored in the microcatheter and cannot be advanced or retracted.The cause of the embolic coil being anchored in the microcatheter cannot be determined from observation of the returned device.100% of devices are inspected at final assembly, including advancing the embolic coil out of the introducer and retracting it back in per 103002467 rev.12.Damage to the embolic coil sufficient to cause resistance when advancing through a microcatheter would be observed and rejected at this inspection.Thus, it is unlikely that the device left the manufacturing facility with damage that would cause the embolic coil to become anchored in a microcatheter.Device history lot: a review of manufacturing documentation associated with this lot (s13314) 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 still inside the rhv and the microcatheter with the embolic coil anchored at an unknown distance inside the catheter, evaluation could not be performed.The condition of the embolic coil could not be confirmed through visual or microscopic analysis.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Devices undergo 100% testing for resistance after being loaded into the packaging hoop.In addition, 100% of devices undergo inspection for damage to the embolic coil at final assembly including advancing and retracting the embolic coil in and out of the introducer.Damage such as an unraveled coil would have been observed and rejected at this inspection point.Thus, it is unlikely that the deltafill18 14 mm x 45 cm coil left the manufacturing facility in a damaged state that would have caused it to become anchored in the microcatheter.The exact cause of the reported malfunction could not be conclusively determined.However, it is possible that the circumstances of the procedure and/or the manipulation and interaction of the devices may have contributed to the reported issue.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.

• Brand Name: DELTAFILL18 14MM X 45CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7623488
• Report Number: 3008114965-2018-00642
• Device Sequence Number: 1623110
• Product Code: KRD
• UDI-Device Identifier: 10886704077138
• UDI-Public: 10886704077138
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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: 02/29/2020
• Device Catalogue Number: DLF181445
• Device Lot Number: S13314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1