MAUDE Adverse Event Report: SEE H.10 DELTAPLUSH COIL, 10 SYS 3X4; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DPL10030420
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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: deltaplush coil 10 sys 3x6, enpower control cable.The initial reporter phone is not known.[conclusion]: the healthcare professional reported that during the coil embolization procedure, the deltaplush coil, 10 sys 3x4 (dlp10030420 / s10825) was used; the enpower control cable and the system to detach the coil was tested with all the lights illuminated.The deltaplush coil was connected but the system did not show a green light to detach the coil.The coil was replaced with another deltaplush coil (the deltaplush coil, 10 sys 3x6).The green light did not turn on; the system was turned off and back on again before the green light illuminated and the coil was detached.It was confirmed that all the connections appear to fit properly without any excessive force.The same control cable and detachment control box (dcb) were used with subsequent coils in the procedure.There was no report of patient injury or complication associated with the reported event.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (s10825) 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.
Event or Problem Description
The healthcare professional reported that during the coil embolization procedure, the deltaplush coil, 10 sys 3x4 (dlp10030420 / s10825) was used; the enpower control cable and the system to detach the coil was tested with all the lights illuminated.The deltaplush coil was connected but the system did not show a green light to detach the coil.The coil was replaced with another deltaplush coil (the deltaplush coil, 10 sys 3x6).The green light did not turn on; the system was turned off and back on again before the green light illuminated and the coil was detached.It was confirmed that all the connections appear to fit properly without any excessive force.The same control cable and detachment control box (dcb) were used with subsequent coils in the procedure.There was no report of patient injury or complication associated with the reported event.

• Brand Name: DELTAPLUSH COIL, 10 SYS 3X4
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7570031
• Report Number: 3008114965-2018-00630
• Device Sequence Number: 179040
• Product Code: KRD
• UDI-Device Identifier: 00878528008118
• UDI-Public: 00878528008118
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K083646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2018

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: 05/31/2021
• Device Catalogue Number: DPL10030420
• Device Lot Number: S10825
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1