MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 7MM X 33CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF180733
Medical Device Problem Codes	Separation Failure (2547); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
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, and ethnicity 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 of a pulmonary arteriovenous malformation (avm), the 7mm x 33cm deltafill 18 coil (dlf180733 / l16350) was used as a filling coil.The complaint documented that it was not clear if a pre-deployment electrical check was performed.The complaint coil was inserted and connected to the connector at the detachment point.However, the light was not illuminated.The physician reconnected several times and the light illuminated.The physician pressed the detachment button and the audible beep signal was heard, but the coil was not able to be detached.The physician made several more attempts but the same issue continued.The complaint coil was replaced with another coil and the procedure was successfully completed.It was reported that the physician suspected the position of the detachment marker may have been out of position because the coil did not come out of the microcatheter even though the reverse t exceeded the second micro marker.There was no report of any patient adverse event or complication as a result of the reported product issue.Based on complaint information, the device was not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (l16350) 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.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 available and without the product available for analysis, the reported issue documented in the complaint cannot be confirmed.Based on the manufacturing documentation review, 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 information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, the target size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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 a coil embolization of a pulmonary arteriovenous malformation (avm), the 7mm x 33cm deltafill 18 coil (dlf180733 / l16350) was used as a filling coil.The complaint documented that it was not clear if a pre-deployment electrical check was performed.The complaint coil was inserted and connected to the connector at the detachment point.However, the light was not illuminated.The physician reconnected several times and the light illuminated.The physician pressed the detachment button and the audible beep signal was heard, but the coil was not able to be detached.The physician made several more attempts but the same issue continued.The complaint coil was replaced with another coil and the procedure was successfully completed.It was reported that the physician suspected the position of the detachment marker may have been out of position because the coil did not come out of the microcatheter even though the reverse t exceeded the second micro marker.There was no report of any patient adverse event or complication as a result of the reported product issue.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 12 july 2021.E.1: the initial reporter phone: (b)(6).[additional information]: the healthcare professional reported that during a coil embolization of a pulmonary arteriovenous malformation (avm), the 7mm x 33cm deltafill 18 coil (dlf180733 / l16350) was used as a filling coil.The complaint documented that it was not clear if a pre-deployment electrical check was performed.The complaint coil was inserted and connected to the connector at the detachment point.However, the light was not illuminated.The physician reconnected several times and the light illuminated.The physician pressed the detachment button and the audible beep signal was heard, but the coil was not able to be detached.The physician made several more attempts but the same issue continued.The complaint coil was replaced with another coil and the procedure was successfully completed.It was reported that the physician suspected the position of the detachment marker may have been out of position because the coil did not come out of the microcatheter even though the reverse t exceeded the second micro marker.There was no report of any patient adverse event or complication as a result of the reported product issue.On 12 july 2021, additional information was received.The information indicated that there was no report that the 7mm x 33cm deltafill 18 coil appeared damaged.It is unclear how far the marker band moved out of position, but the coil part did not come out of the micro even though the reverse t exceeded the second micro marker.No further information was provided.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 7MM X 33CM
• 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: 12103691
• Report Number: 3008114965-2021-00249
• Device Sequence Number: 3529626
• Product Code: KRD
• UDI-Device Identifier: 10886704076940
• UDI-Public: 10886704076940
• 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): 06/15/2021

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: 06/30/2022
• Device Model Number: DLF180733
• Device Catalogue Number: DLF180733
• Device Lot Number: L16350
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1