MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAXSFT10 1.5MM X 3CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLX100153
Medical Device Problem Codes	Stretched (1601); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2020-00303.Complaint conclusion: as reported by the field, during a coil embolization, re-sheathing failed with a 1.5mm x 3cm deltaxsft10 (dlx100153, l15277 ) and a 6x15 og tdl cmplx fill coil (640cf0615, 17710987).The procedure was successfully finished.There was no patient injury reported.Based on the findings of the device investigation, the embolic coil was noted to being stretched and kinked on the deltaxsft10.A non-sterile unit deltaxsft10 1.5mm x 3cm was received inside of a pouch.The device was inspected, and it was found that the introducer has a kinked condition, the dpu was inspected and it was found kinked at 132 cm from proximal.Also, the marker band was found at 38 cm from hub, which is within specification.The embolic coil was inspected under microscope and it was found with a stretch and kinked condition, also it was found protruded from the introducer.The functional analysis could not be performed due to the kinked condition noted on the introducer and the coil protruded from introducer.A manufacturing record evaluation was performed for the finished device l15277 number, and no non-conformances related to the reported complaint condition were identified the complaint reported by the customer ¿coil introducer - zipping difficulty-rezipping¿ was confirmed, during the inspection it was noted that the introducer has a kinked condition, also it was noted that the embolic coil is protruded from the introducer, due to this condition, the complaint reported by the costumer can be confirmed.The kinked condition noted on the embolic coil and the introducer could be related with the costumer complaint and may have appeared to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.Neither the analysis nor the mre suggest that the failure reported by the costumer could be related to the manufacturing process.The instructions for use (ifu) instructs the user to unsheathe a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the resheathing tool.This results in the placement of the embolic coil and the more flexible and fragile distal sections of the dpu inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing into the microcatheter, there is a risk that the embolic coil or the distal end of the dpu will be unsheathed and pass through the resheathing tool.If the resheathing tool passes over the distal end of the dpu, this will expose these flexible sections, which will then be subject to kinking and bending.Once a part of the dpu is kinked or bent, the translucent introducer sheath will not be able to re-form around it, and that section of the device will protrude.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.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.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, re-sheathing failed with a 1.5mm x 3cm deltaxsft10 (dlx100153, l15277 ) and a 6x15 og tdl cmplx fill coil (640cf0615, 17710987).The procedure was successfully finished.There was no patient injury reported.Based on the findings of the device investigation, the embolic coil was noted to being stretched and kinked on the deltaxsft10.The embolic coil was found stretched on the og tdl cmplx fill coil.

• Brand Name: DELTAXSFT10 1.5MM X 3CM
• 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: 10333059
• Report Number: 3008114965-2020-00302
• Device Sequence Number: 3209710
• Product Code: KRD
• UDI-Device Identifier: 10886704077268
• UDI-Public: 10886704077268
• 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
• Report Date (Section B): 05/17/2020

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: 02/28/2022
• Device Model Number: DLX100153
• Device Catalogue Number: DLX100153
• Device Lot Number: L15277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1