MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAXSFT10 1.5MM X 1CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLX100151
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2020
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: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Based on the photos provided by the account, the analysis of the failure reported by the client cannot be conclusively determined because only the product label can be seen in the photo provided.A manufacturing record evaluation was performed for the finished device l16085 number, and no non-conformances related to the reported complaint condition were identified.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization, a 1.5mm x 1cm deltaxsft10 coil (deltaxsft, l16085) was being used as the final finishing coil.After the coil detached and was removed from the excelsior microcatheter (mc), there was ¿something sticking out¿ at the end of the mc.The procedure was well completed.There was no patient injury reported.The device was removed from the patient without additional intervention.The device(s) were used and prepped as per the instructions for use.The concomitant devices functioned as expected.There was no device fragments that remained in the patient.There was no excessive force applied to the device.There was no difficulty with device positioning.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 a healthcare professional, during a coil embolization, a 1.5mm x 1cm deltaxsft10 coil (deltaxsft, l16085) was being used as the final finishing coil.After the coil detached and was removed from the excelsior microcatheter (mc), there was ¿something sticking out¿ at the end of the mc.The procedure was well completed.There was no patient injury reported.The device was removed from the patient without additional intervention.The device(s) were used and prepped as per the instructions for use.The concomitant devices functioned as expected.There was no device fragments that remained in the patient.There was no excessive force applied to the device.There was no difficulty with device positioning.One non-sterile deltaxsft10 1.5mm x 3cm unit was received inside of a pouch.Also, one excelsior mc (non-j&j product) was received inside the pouch.The received device was visually inspected, no damages were noted on it.Then a microscopic inspection was performed, the distal outer sheath was found heated and the embolic coil was not returned with the device.No other damages were observed.Also, the marker band was found at 36.1cm from distal end which is within specification.An x-ray was performed to the excelsior mc (non-j&j product).According to the event, something was stuck in the final part of this mc (embolic coil).Nothing was found in the distal part of the received mc.A manufacturing record evaluation was performed for the finished device l16085 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿marker band- offset/out of position¿ was not confirm.The marker band was found within specification.Neither the product analysis nor the mre suggest that the failure reported could be related to the 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.

• Brand Name: DELTAXSFT10 1.5MM X 1CM
• 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: 9745203
• Report Number: 3008114965-2020-00028
• Device Sequence Number: 713594
• Product Code: KRD
• UDI-Device Identifier: 10886704077244
• UDI-Public: 10886704077244
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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: 05/31/2022
• Device Model Number: DLX100151
• Device Catalogue Number: DLX100151
• Device Lot Number: L16085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/02/2020
• 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: EXCELSIOR MICROCATHETER