MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 10MM X 40CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF181040
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
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.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that during a coil embolization procedure for a pre-stent graft, the 10mm x 40cm deltafill 18 coil (dlf181040 / 30393155) was used as the second coil.It was reported that the coil part became bent in a concomitant microcatheter and as a result, could not be delivered.It was replaced with another 10mm x 40cm deltafill 18 coil and the replacement coil was implanted without any problems.There was no report of any patient adverse event as a result of 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 (30393155) 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.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information provided in the complaint and without the complaint product and the concomitant microcatheter available for analyses, the reported issues by the customer cannot be confirmed.Based on the review of the manufacturing documentation, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 a coil embolization procedure for a pre-stent graft, the 10mm x 40cm deltafill 18 coil (dlf181040 / 30393155) was used as the second coil.It was reported that the coil part became bent in a concomitant microcatheter and as a result, could not be delivered.It was replaced with another 10mm x 40cm deltafill 18 coil and the replacement coil was implanted without any problems.There was no report of any patient adverse event as a result of the reported event.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 27 may 2021.E.1: the initial reporter phone:(b)(6).[additional information]: the healthcare professional reported that during a coil embolization procedure for a pre-stent graft, the 10mm x 40cm deltafill 18 coil (dlf181040 / 30393155) was used as the second coil.It was reported that the coil part became bent in a concomitant microcatheter and as a result, could not be delivered.It was replaced with another 10mm x 40cm deltafill 18 coil and the replacement coil was implanted without any problems.There was no report of any patient adverse event as a result of the reported event.On 27 may 2021, additional information was received indicated that continuous flush had not been maintained through the concomitant microcatheter.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): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 11806803
• Report Number: 3008114965-2021-00170
• Device Sequence Number: 17028141
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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: 04/30/2023
• Device Model Number: DLF181040
• Device Catalogue Number: DLF181040
• Device Lot Number: 30393155
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1