MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 6MM X 25CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF180625
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2020
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 mechanically detached, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, ethnicity was not reported.Procode: krd/hcg initial reporter phone : (b)(6).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 at both internal iliac arteries (iia), a sheath introducer (4fr25¿.Medikit) was used.A 6mm x 25cm deltafill18 coil (dlf180625, l16942) was inserted into a concomitant microcatheter (breakthrough, boston scientific).However, there was a resistance felt between the complaint coil the microcatheter the resistance made the sheath introducer damage.The complaint coil was replaced with another same sized coil the procedure was completed.The customer states there is no additional information available.The findings of the device investigation indicated that the embolic coil was noted to being stretched mechanically detached.One non-sterile unit deltafill18 8mm x 35cm was received inside of a pouch.The received device was visually inspected, the introducer was found damaged separated from the unit.Then a microscopic analysis was performed, the embolic coil was found stretched mechanically detached.No other damages were observed.The complaint reported by the customer ¿coil introducer ¿ damaged¿ was confirm, the introducer was found damaged.The complaint reported by the customer ¿ detachable coil delivery system (dcs)¿ resistance/friction-during advancement with no loss of cerebral target position¿ could not be evaluated due the conditions of the received device, however the embolic coil was found stretched this may have contributed to the resistance/friction felt.The damaged condition appears to have been caused by excessive force.Neither the analysis nor the mre suggest that the failure reported could be related to the manufacturing process.The instructions for use (ifu) states that continuous infusion of an appropriate flush solution is required for optimal performance indicates that the flush should be verified in the event of resistance/friction during device advancement.Insufficient flush allows blood to back-flow into the microcatheter, which can cause resistance/friction.The instructions for use (ifu) caution that if unusual friction is still noticed during advancement or retraction of the coil system, verify flush lines are open properly pressurized.Then slowly withdraw the entire catheter system examine for damage.Replace it with a new system.If friction still exists, withdraw examine the delivery catheter system.Assignment of root cause for the event remains speculative inconclusive, based on the limited information provided the evidence presented by the returned device; however, it is possible that clinical procedural factors, including device manipulation device interaction, may have contributed to the reported failure damages on the returned system.An embolic coil becomes stretched when an excessive pull force is applied to the device.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 a healthcare professional, during a coil embolization at both internal iliac arteries (iia), a sheath introducer (4fr25¿.Medikit) was used.A 6mm x 25cm deltafill18 coil ((b)(4), l16942) was inserted into a concomitant microcatheter (breakthrough, boston scientific).However, there was a resistance felt between the complaint coil and the microcatheter and the resistance made the sheath introducer damage.The complaint coil was replaced with another same sized coil and the procedure was completed.The customer states there is no additional information available.The findings of the device investigation indicated that the embolic coil was noted to being stretched, and mechanically detached.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Upon further review, this complaint does not meet the criteria for medical device reporting since the device that was received and analyzed under this complaint corresponds to another file.The device involved in this complaint was not returned.Therefore, it has been deemed not reportable.No further reports will be forthcoming.A manufacturing record evaluation was performed for the finished device l16942 number, and no non-conformances related to the reported complaint condition were identified.Since no device has been received for analysis, no product investigation can be performed and the reported failure could not be evaluated.

• Brand Name: DELTAFILL18 6MM X 25CM
• 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: 10000357
• Report Number: 3008114965-2020-00137
• Device Sequence Number: 11285979
• Product Code: KRD
• UDI-Device Identifier: 10886704076933
• UDI-Public: 10886704076933
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2020

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: DLF180625
• Device Catalogue Number: DLF180625
• Device Lot Number: L16942
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 06/08/2020
• 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: 4FR 25¿. MEDIKIT SHEATH INTRODUCER; BREAKTHROUGH, BOSTON SCIENTIFIC MICROCATHETER