MAUDE Adverse Event Report: SEE H.10 DELTAFILL18 3MM X 12CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF180312
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2018
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 name, phone and email address of the initial reporter is unknown.[conclusion]: the healthcare professional reported that during the procedure to treat an unruptured aneurysm in a (b)(6) female patient, during the delivery of the deltafill 18 3 mm x 12 cm coil (dlf180312 / l10330), the coil prematurely detached before it was fully inserted into the aneurysm.The physician was able to push the coil into the aneurysm using the coil delivery wire and the coil was implanted.The event did not result in any clinical delay.There was no report of patient injury or adverse event associated with the reported issue.Based on complaint information the deltafill 18 3 mm x 12 cm coil remains implanted and is thus, not available to be returned for analysis.A review of manufacturing documentation associated with this lot (l10330) 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.With the limited information available and without the product being available for analysis, the reported customer complaint could not be confirmed.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 event could not be conclusively determined; however, it is possible that circumstances of the procedure and/or device manipulation/interaction may have contributed to the reported failure.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 procedure to treat an unruptured aneurysm in a (b)(6) female patient, during the delivery of the deltafill 18 3 mm x 12 cm coil (dlf180312 / l10330), the coil prematurely detached before it was fully inserted into the aneurysm.The physician was able to push the coil into the aneurysm using the coil delivery wire and the coil was implanted.The event did not result in any clinical delay.There was no report of patient injury or adverse event associated with the reported issue.

• Brand Name: DELTAFILL18 3MM X 12CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7786975
• Report Number: 3008114965-2018-00705
• Device Sequence Number: 2061335
• Product Code: KRD
• UDI-Device Identifier: 10886704077190
• UDI-Public: 10886704077190
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2018

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: 09/30/2020
• Device Catalogue Number: DLF180312
• Device Lot Number: L10330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2018
• 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
• Patient Age: 63 YR