MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 12MM X 42CM

Catalog Number	DLF181242
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
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 phone: (b)(6).Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).The company is seeking this information through the event investigation.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2019-01073.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by an affiliate, during a coil embolization, there was strong resistance felt between a microcatheter and two coils.A deltafill18 20mm x 60cm (dlf182060, l14332) and a deltafill18 12mm x 42cm ((dlf181242, l14321).The physician attempted to remove the complaint coils, however, both coils got stuck in the middle of the microcatheter and they unraveled in the microcatheter.After that, the microcatheter with the complaint coils were removed together from the patient¿s body, and the complaint coils were removed from the microcatheter.The procedure was completed by approaching the same microcatheter again to the target lesion and non-cerenovus coils were advanced smoothly in the microcatheter without getting stuck.Additional information received indicated that there was no excessive force applied to the devices.The devices were used and prepped as per the instructions for use.No further information was provided by hospital.
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 an affiliate, during a coil embolization, there was strong resistance felt between a microcatheter and two coils.A deltafill18 20mm x 60cm (dlf182060, l14332) and a deltafill18 12mm x 42cm ((dlf181242, l14321).The physician attempted to remove the complaint coils, however, both coils got stuck in the middle of the microcatheter and they unraveled in the microcatheter.After that, the microcatheter with the complaint coils were removed together from the patient¿s body, and the complaint coils were removed from the microcatheter.The procedure was completed by approaching the same microcatheter again to the target lesion and non-cerenovus coils were advanced smoothly in the microcatheter without getting stuck.Additional information received indicated that there was no excessive force applied to the devices.The devices were used and prepped as per the instructions for use.No further information was provided by hospital.The device was discarded and therefore it is not available for analysis.A manufacturing record evaluation was performed for the finished device l14321 number, and no non-conformances related to the reported complaint condition were identified.With the information available and without the product available for analysis, the reported customer complaints of ¿detachable coil delivery system (dcs) - impeded in microcatheter with no loss of cerebral target position¿ and ¿coil - unraveled/stretched-in microcatheter¿ could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.The ifu includes warnings and instructions for use to trouble shoot this type of situation.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: DELTAFILL18 12MM X 42CM
• Common Device Name: DELTAFILL
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 8753074
• Report Number: 3008114965-2019-01074
• Device Sequence Number: 1690552
• Product Code: KRD
• UDI-Device Identifier: 10886704077121
• UDI-Public: 10886704077121
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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: 10/31/2021
• Device Catalogue Number: DLF181242
• Device Lot Number: L14321
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 07/30/2019
• 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: MICROCATHETER