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	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (30478863) 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.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 coil embolization procedure at the internal iliac artery, the 10mm x 40cm deltafill 18 coil (dlf181040 / 30478863) was being delivered but it became slightly kinked.The kink resulted in an intense resistance between the coil and the concomitant carnelian® marvel® (tokai medical products).The complaint coil was replaced and the procedure was completed.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: pc-(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 event info]: the healthcare professional reported that during the coil embolization procedure at the internal iliac artery, the 10mm x 40cm deltafill 18 coil (dlf181040 / 30478863) was being delivered but it became slightly kinked.The kink resulted in an intense resistance between the coil and the concomitant carnelian® marvel® (tokai medical products).The complaint coil was replaced and the procedure was completed.There was no report of any patient adverse event or complication.On 27 may 2021, additional information was received indicated that continuous flush had not been maintained through the concomitant carnelian® marvel® microcatheter.Updated sections: e.1, e.3, g.3, g.6.H.2, and h.10.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the coil embolization procedure at the internal iliac artery, the 10mm x 40cm deltafill 18 coil (dlf181040 / 30478863) was being delivered but it became slightly kinked.The kink resulted in an intense resistance between the coil and the concomitant carnelian® marvel® (tokai medical products).The complaint coil was replaced and the procedure was completed.There was no report of any patient adverse event or complication.On 27 may 2021, additional information was received indicated that continuous flush had not been maintained through the concomitant carnelian® marvel® microcatheter.The device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 10mm x 40cm deltafill 18 coil was received contained in a pouch.Visual inspection was performed.The device positioning unit (dpu) was observed kinked at 74 cm from the proximal end.No other damage nor anomaly was observed during the visual inspection.The returned device underwent a microscopic inspection.The embolic coil was observed in good, normal condition.No damage was observed.Based on the microscopic inspection of the returned device, the reported issue documented in the complaint that during the procedure, the 10mm x 40cm deltafill 18 coil was being delivered but it became slightly kinked was not confirmed.The embolic coil was observed to be in good, normal condition.It was the dpu that was observed kinked.A review of manufacturing documentation associated with this lot (30478863) 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.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instructions for use (ifu) does contain the following cautions: if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.If the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the microcatheter at or slightly inside the ostium (neck) of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.If unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw, and examine the delivery catheter system.Pulling the exposed microcoil through the rotating hemostasis valve (rhv) grommet may damage the coil.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 21 april 2021.A supplemental 3500a report will be submitted once the product investigation has been completed.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: 11649820
• Report Number: 3008114965-2021-00128
• Device Sequence Number: 14291787
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/24/2021

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: 10/31/2023
• Device Model Number: DLF181040
• Device Catalogue Number: DLF181040
• Device Lot Number: 30478863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 04/21/2021; 05/27/2021; 05/28/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 04/21/2021; 05/27/2021; 05/28/2021
• 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: CARNELIAN® MARVEL® (TOKAI MEDICAL PRODUCTS)