MAUDE Adverse Event Report: SEE H.10 DELTAFILL10 3MM X 8CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF100308
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.Date of event: the event occurred in 2018, however, the month and date of the event were not reported.Pro code is krd/hcg.(b)(4).Initial reporter information such as facility name, address, and the name, phone and email address are unknown.This information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.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, several attempts were made to detach the deltafill 10 3mm x 8cm coil (dlf100308 / lot# not available) but the coil did not detach; it was also reported that during the attempt to detach the coil, movement was created in the microcatheter.There was no report of patient injury or adverse event.

• Brand Name: DELTAFILL10 3MM X 8CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8097571
• Report Number: 3008114965-2018-00797
• Device Sequence Number: 1902996
• Product Code: KRD
• UDI-Device Identifier: 10886704077046
• UDI-Public: 10886704077046
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 11/06/2018

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 Catalogue Number: DLF100308
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1