MAUDE Adverse Event Report: SEE H.10 DELTAFILL18 10MM X 40CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF181040
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2018
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: prowler select plus (606s255x / 17738047).(b)(6).[conclusion]: the healthcare professional reported that during the procedure, when the deltafill 18 10 mm x 40 cm (dlf181040 / s13437) was inserted into the microcatheter, a prowler select plus (606s255x / 17738047), there was strong resistance felt at the tip of the microcatheter, as a result, the coil could not be advanced.The physician attempted to remove the coil by withdrawing it from the microcatheter.The coil became unraveled in the microcatheter.The coil and the microcatheter were both removed.The coil was replaced and the procedure was successfully completed without further issue 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 in the vessel or in the microcatheter.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (s13437) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of causes and possible contributing factors could be made.As such the investigation will be closed.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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the procedure, when the deltafill 18 10 mm x 40 cm (dlf181040 / s13437) was inserted into the microcatheter, a prowler select plus (606s255x / 17738047), there was strong resistance felt at the tip of the microcatheter, as a result, the coil could not be advanced.The physician attempted to remove the coil by withdrawing it from the microcatheter.The coil became unraveled in the microcatheter.The coil and the microcatheter were both removed.The coil was replaced and the procedure was successfully completed without further issue 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 in the vessel or in the microcatheter.
Additional Manufacturer Narrative
(b)(4).[conclusion]: the healthcare professional reported that during the balloon-occluded retrograde transvenous obliteration (brto) procedure, when the deltafill 18 10 mm x 40 cm (dlf181040 / s13437) was inserted into the microcatheter, a prowler select plus (606s255x / 17738047), there was strong resistance felt at the tip of the microcatheter, as a result, the coil could not be advanced.There was no resistance between the guidewire and the microcatheter when the physician was accessing the target site.The physician attempted to remove the coil by withdrawing it from the microcatheter.The coil became unraveled in the microcatheter.The coil and the microcatheter were both removed.The coil was replaced and the procedure was successfully completed without further issue 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 in the vessel or in the microcatheter.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (s13437) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of causes and possible contributing factors could be made.As such the investigation will be closed.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 10MM X 40CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7537814
• Report Number: 3008114965-2018-00634
• Device Sequence Number: 1433248
• Product Code: KRD
• UDI-Device Identifier: 10886704077114
• UDI-Public: 10886704077114
• 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): 05/02/2018

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: DLF181040
• Device Lot Number: S13437
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1