MAUDE Adverse Event Report: SEE H.10 DELTAFILL18 8MM X 35CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF180835
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).Initial reporter information such as the name, phone and email address are not available / unknown.(b)(6).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.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 to treat an aneurysm for a pre-stent graft at the internal iliac artery, the 8 mm x 35 cm deltafill 18 coil (dlf180835 / l12821) was the fourth coil used.The deltafill 18 coil did not detach with the enpower control cable (ecb00018200 / l12420); the enpower control cable was replaced with another from the same lot (l12420) and the same issue was experienced.The coil did not detach.Imaging was taken, and it was confirmed that the aneurysm was sufficiently embolized so additional coils were not used.The procedure was completed without 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.There was no unintended detachment observed in the vessel or in the microcatheter.The product is reported as available to be returned for evaluation and analysis.
Additional Manufacturer Narrative
(b)(4).The purpose of this mdr submission is to report that the product was received by cerenovus product analysis lab on 2/11/2019.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on (b)(6) 2019.Information was added to the following sections: initial reporter title, initial reporter first and last names.Initial reporter phone: (b)(6).[additional information]: the healthcare professional reported that during the coil embolization procedure to treat an aneurysm for a pre-stent graft at the internal iliac artery, the 8 mm x 35 cm deltafill 18 coil (dlf180835 / l12821) was the fourth coil used.The deltafill 18 coil did not detach with the enpower control cable (ecb00018200 / l12420); the enpower control cable was replaced with another from the same lot (l12420) and the same issue was experienced.The coil did not detach and was successfully removed from the patient.Imaging was taken, and it was confirmed that the aneurysm was sufficiently embolized so additional coils were not used.The procedure was completed without 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.There was no unintended detachment observed in the vessel or in the microcatheter.It was confirmed that a pre-deployment check was performed.All connections appeared to fit properly without the application of excessive force.The product was received by the cerenovus product analysis lab on 2/11/2019 and is pending evaluation and analysis.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to document the result of the analysis of the production records for lot s13661.A review of manufacturing documentation associated with this lot (l12821) 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 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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the coil embolization procedure to treat an aneurysm for a pre-stent graft at the internal iliac artery, the 8 mm x 35 cm deltafill 18 coil (dlf180835 / l12821) was the fourth coil used.The deltafill 18 coil did not detach with the enpower control cable (ecb00018200 / l12420); the enpower control cable was replaced with another from the same lot (l12420) and the same issue was experienced.The coil did not detach and was successfully removed from the patient.Imaging was taken, and it was confirmed that the aneurysm was sufficiently embolized so additional coils were not used.The procedure was completed without 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.There was no unintended detachment observed in the vessel or in the microcatheter.It was confirmed that a pre-deployment check was performed.All connections appeared to fit properly without the application of excessive force.The product was received, and the evaluation has been completed.The investigational finding is documented below.Investigation summary: a non-sterile 8 mm x 35 cm deltafill 18 coil was received contained in a pouch.The returned device underwent visual inspection and the device positioning unit (dpu) was observed to be compressed, twisted, and partially broken near the extended coil.No other damages were observed on the device.Under microscopic inspection, the extended coil was observed to be compressed, twisted, and partially broken.The resistance heating (rh) showed evidence of being heated.Functional test was performed.The resistance of the device could not be measured due to the broken section on the dpu.The 8 mm x 35 cm deltafill 18 coil was connected to the lab detachment control box with the received the two enpower connecting cables (ecb00018200) from the same lot (l12420) and the system ready light did not illuminate.A review of manufacturing documentation associated with this lot (l12821) 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 issue that the 8 mm x 35 cm deltafill 18 coil failed to detach was confirmed during the functional test performed on the returned device.The failure of the coil to detach appears to be due to the compressed, twisted, and partially broken dpu noted in the visual and microscopic inspection performed on the returned device.The condition of the received dpu likely blocked the electric signal to the device.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The cause of the compressed, twisted, and broken condition of the dpu could not be conclusively determined.It is possible that circumstances of the procedure and/or device manipulation/interaction may have contributed to the dpu sustaining the damages noted on the returned device which resulted in the reported event of the coil failing to detach.Devices undergo 100% inspection at final assembly, damages such as observed on the dpu of the returned device would have been noted at final inspection.Thus, it is not likely that the 8 mm x 35 cm deltafill 18 coil left the manufacturing facility with the damages observed on the dpu of the 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.Additional information will be submitted within 30 days of receipt.

• Brand Name: DELTAFILL18 8MM X 35CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8287252
• Report Number: 3008114965-2019-00886
• Device Sequence Number: 141505
• Product Code: KRD
• UDI-Device Identifier: 10886704077220
• UDI-Public: 10886704077220
• 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,Followup,Followup,Followup
• Report Date (Section B): 01/11/2019

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: 05/31/2021
• Device Catalogue Number: DLF180835
• Device Lot Number: L12821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 01/30/2019; 02/11/2019; 02/21/2019; 04/08/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 01/30/2019; 02/11/2019; 02/21/2019; 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1