MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAXSFT10 2MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLX100204
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.Procode is krd/hcg.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 the manufacturing documentation associated with this lot (30481266) 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.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 the 2mm x 4cm deltaxsft 10 coil (dlx100204 / 30481266) was the 7th coil used in the procedure and it would not detach after three detachment attempts.The coil was successfully removed from the patient with the coil still attached to the delivery system.Another 2mm x 4cm deltaxsft 10 coil from the same lot was used; this replacement coil detached without any issue using the same concomitant sl-10® microcatheter (stryker); the same microcatheter was used to complete the procedure.It was reported that a pre-deployment electrical check was performed.The lights on the enpower illuminated when the power button was pressed.During the initiated detachment cycle, the detachment light illuminated and the audible signal beep was heard.All connection fit without application of excessive force.The reported issue did not result in any delay in the procedure.There was no report of any patient adverse event or complication.
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 12 july 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.
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 the 2mm x 4cm deltaxsft 10 coil (dlx100204 / 30481266) was the 7th coil used in the procedure and it would not detach after three detachment attempts.The coil was successfully removed from the patient with the coil still attached to the delivery system.Another 2mm x 4cm deltaxsft 10 coil from the same lot was used; this replacement coil detached without any issue using the same concomitant sl-10® microcatheter (stryker); the same microcatheter was used to complete the procedure.It was reported that a pre-deployment electrical check was performed.The lights on the enpower illuminated when the power button was pressed.During the initiated detachment cycle, the detachment light illuminated and the audible signal beep was heard.All connection fit without application of excessive force.The reported issue did not result in any delay in the procedure.There was no report of any patient adverse event or complication.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 2mm x 4cm deltaxsft 10 coil was received contained in a pouch.Visual inspection was performed.The device was observed to be in good, normal condition.No damages nor anomalies were observed during the visual inspection.A microscopic inspection was performed.The embolic coil was observed in good condition without any appearance of damage nor anomaly.Functional evaluation: the resistance of the 2mm x 4cm deltaxsft 10 coil was measured with a multimeter.The initial resistance was measured to be 53.0 o, this is within the specification range of 48.5 o ¿ 56.0 o.The device was connected to a lab sample detachment control box dcb2000500 (dcb) with a lab sample enpower control cable.The power was turned on.The system ready light became illuminated.The detach button was pressed and the embolic coil was detached without problem.A review of the manufacturing documentation associated with this lot (30481266) 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.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 recommendations: verify that the microcoil delivery system is fully connected, and no faults are indicated on the dcb.If a fault exists, reseat all connections between the dpu, the dcb, and the connecting cable.If a fault still persists, replace the connecting cable.If this does not correct the error, replace the dcb.If the microcoil delivery system still continues to have a fault, retrieve the microcoil as described in the following section, re sheathing the microcoil system, and replace with a new microcoil system.The complaint documented that the 2mm x 4cm deltaxsft 10 coil was the 7th coil used in the procedure and it would not detach after three detachment attempts.The reported issue could not be confirmed through functional evaluation and analysis performed on the returned device.There were no evidence of damage nor anomaly observed on the returned device.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Updated sections: g.3, g.6, h.2, h.3, h.6, 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.

• Brand Name: DELTAXSFT10 2MM X 4CM
• 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: 12125563
• Report Number: 3008114965-2021-00253
• Device Sequence Number: 11660794
• Product Code: KRD
• UDI-Device Identifier: 10886704077329
• UDI-Public: 10886704077329
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2021

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: 11/30/2023
• Device Model Number: DLX100204
• Device Catalogue Number: DLX100204
• Device Lot Number: 30481266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 07/12/2021; 08/11/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 07/12/2021; 08/11/2021
• 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: SL-10® MICROCATHETER (STRYKER)
• Patient Age: 59 YR