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

Model Number	DLF181040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter phone: (b)(6).Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
As reported by the filed, during a coil embolization, the physician set the coil sheath of a 10mm x 40cm deltafill18 (dlf181040, l14584) in the hub of a concomitant microcatheter (excelsior1018, stryker).It was set by connecting the y-shaped connector during heparin continuous flush.When the physician tried to insert the complaint coil into the microcatheter by pushing the delivery wire, the hub and the sheath were not crimped enough, and the complaint coil came out about 10 mm from the gap.Therefore, he removed the sheath from the hub and pulled the delivery wire to withdraw the complaint coil inside the sheath.However, the complaint coil could not be pulled.He removed the deltafill18 complaint coil from the sheath by pushing the wire and noticed that the connection part was disconnected.Additional information received indicated that the rhv was not tightened around the introducer sufficiently.No excessive force was applied to the device.Adequate flush had been maintained through the devices.There was no significant procedural delay due to the event.No additional information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section b5: additional information received indicated that the rhv was not tightened around the introducer sufficiently.No excessive force was applied to the device.Adequate flush had been maintained through the devices.There was no significant procedural delay due to the event.No additional information is available.Section e1 - initial reporter phone: (b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a coil embolization, the physician set the coil sheath of a 10mm x 40cm deltafill18 (dlf181040, l14584) in the hub of a concomitant microcatheter (excelsior1018, stryker).It was set by connecting the y-shaped connector during heparin continuous flush.When the physician tried to insert the complaint coil into the microcatheter by pushing the delivery wire, the hub and the sheath were not crimped enough, and the complaint coil came out about 10 mm from the gap.Therefore, he removed the sheath from the hub and pulled the delivery wire to withdraw the complaint coil inside the sheath.However, the complaint coil could not be pulled.He removed the deltafill18 complaint coil from the sheath by pushing the wire and noticed that the connection part was disconnected.Additional information received indicated that the rhv was not tightened around the introducer sufficiently.No excessive force was applied to the device.Adequate flush had been maintained through the devices.There was no significant procedural delay due to the event.No additional information is available.The device was discarded; therefore, no product investigation can be performed.A manufacturing record evaluation was performed for the finished device l14584 number, and no non-conformances related to the reported complaint condition were identified.With the information available and without the product available for analysis, the reported customer complaints of ¿coil introducer - incompatibility/fit-with rh valve¿ and ¿coil - premature detachment-prior to use¿ could not be confirmed.Based on the device history record review, there is no indication that the events are related to the device manufacturing process.Premature coil deployment in microcatheter is a known potential complication associated with the use of the deltafill18.The instructions for use (ifu) contains instructions and cautions regarding proper placement of the device, including introduction and positioning of the microcoil.Assignment of root cause for the events remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device; however, it is possible that clinical and procedural factors, including device manipulation / interaction and device selection may have contributed to the reported issues.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• 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: 10471596
• Report Number: 3008114965-2020-00391
• Device Sequence Number: 19567844
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

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: 12/31/2021
• Device Model Number: DLF181040
• Device Catalogue Number: DLF181040
• Device Lot Number: L14584
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 08/30/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR1018 MICROCATHETER , STRYKER; EXCELSIOR1018 MICROCATHETER , STRYKER