MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 8MM X 35CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF180835
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2020
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, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and 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 the internal iliac artery, a 8mm x 35cm deltafill18 coil (dlf180835, l17164) was inserted and advanced for filling.However, the sheath introducer got damaged when it was attempted to be peeled away.It was not able to be re-sheathed.Other four coils were used without any problems.No excessive force had been applied to attempt to un-zip or re-zip the introducer.The customer states there is no additional information available.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 and partially zipped.Then a microscopic analysis was performed, and the embolic coil was found stretched and partially inside the introducer.No other damages were observed.A manufacturing record evaluation was performed for the finished device l17164 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil introducer ¿ damaged-during prep¿ was confirm, the introducer was found damaged and partially zipped.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.Per the instructions for use (ifu), visually examine the coil system for any anomalies such as kinks, burrs, stretched coil, striations, or other damages.If any anomalies are noted or if there is difficulty advancing the coil system from the introducer sheath, the unit may be defective.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 a healthcare professional, during a coil embolization at the internal iliac artery, an 8mm x 35cm deltafill18 coil (dlf180835, l17164) was inserted and advanced for filling.However, the sheath introducer got damaged when it was attempted to be peeled away.It was not able to be re-sheathed.Other four coils were used without any problems.No excessive force had been applied to attempt to un-zip or re-zip the introducer.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.

• Brand Name: DELTAFILL18 8MM X 35CM
• 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: 10005838
• Report Number: 3008114965-2020-00134
• Device Sequence Number: 11459378
• Product Code: KRD
• UDI-Device Identifier: 10886704077220
• UDI-Public: 10886704077220
• 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
• Report Date (Section B): 03/09/2020

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: 09/30/2022
• Device Model Number: DLF180835
• Device Catalogue Number: DLF180835
• Device Lot Number: L17164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1