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

Model Number	DLX100202
Medical Device Problem Codes	Stretched (1601); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was noted to being stretched and kinked, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.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 of an unknown target vessel/site, while advancing a 2mm x 2cmthe delta xsft coil (dlx100202, l16827), it was impossible to pushed out into the echelon10, medtronic microcatheter (dlx100202 lot l16827).Even after several attempts it was not possible to push forward through the catheter.Further coils were easily pushed in without any problems.No patient harm nor surgical delay reported.The device was used and prepped as per the instructions for use, however, it was not checked in advance.No excessive force had been applied to the device.The event occurred outside the patient.Adequate flush had been maintained through the devices.Based on the product investigation, the embolic coil was noted to being stretched and kinked.One non-sterile unit deltaxsft10 2mm x 2cm was received inside of a pouch.The received device was visually inspected, the dpu was found several kinked and protruded from the introducer, then a microscopic inspection was performed and the embolic coil was found stretched and kinked inside of the introducer.No other damages were observed.The marker band was found at 37cm approximately from distal end and it was found within specification.A manufacturing record evaluation was performed for the finished device l16827 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿detachable coil delivery system (dcs) ¿ impeded with no loss of cerebral target position¿ was confirmed.The dpu of the device was found kinked and the embolic coil was found kinked and stretched inside the introducer and these two conditions combined may have contributed to an impediment.The kinked and stretched condition appears to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.Neither the mre suggest that the failure reported could be related to the manufacturing process.The instructions for use (ifu) warns that if the microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.
Event or Problem Description
As reported by the field, during a coil embolization of an unknown target vessel/site, while advancing a 2mm x 2cmthe delta xsft coil (dlx100202, l16827), it was impossible to pushed out into the echelon10, medtronic microcatheter (dlx100202 lot l16827).Even after several attempts it was not possible to push forward through the catheter.Further coils were easily pushed in without any problems.No patient harm nor surgical delay reported.The device was used and prepped as per the instructions for use, however, it was not checked in advance.No excessive force had been applied to the device.The event occurred outside the patient.Adequate flush had been maintained through the devices.Based on the product investigation, the embolic coil was noted to being stretched and kinked.

• Brand Name: DELTAXSFT10 2MM X 2CM
• 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: 10367781
• Report Number: 3008114965-2020-00326
• Device Sequence Number: 19549521
• Product Code: KRD
• UDI-Device Identifier: 10886704077305
• UDI-Public: 10886704077305
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2020

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: 08/31/2022
• Device Model Number: DLX100202
• Device Catalogue Number: DLX100202
• Device Lot Number: L16827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1