MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 20MM X 60CM

Catalog Number	DLF182060
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
(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 device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 3008114965-2019-01074.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).Updated sections: d10, g4, g7, h2, h3, and h6.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.A deltafill18 20mm x 60cm coil was received for analysis.Based on the visual inspections, the hub and heated resistance (not heated) appear in normal condition.Dpu is damaged (kinked at distal tip).Re-sheating tool, coil and introducer were not returned with the device.Marker band was found at 95 cm from distal end and it was found within specification.The reported condition ¿unraveled/stretched-in microcatheter¿ and "impeded in microcatheter with no loss of cerebral target position" could not be evaluated due to the dpu is damaged and re-sheating tool, coil and introducer were not returned with device.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint were identified.The customer complaint ¿unraveled/stretched-in microcatheter¿ and "impeded in microcatheter with no loss of cerebral target position" cannot be confirmed since the dpu was observed damage and the coil and introducer were not returned with the device.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.Impeded in microcatheter is a known potential product failure associated with the use of the device.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 these events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: DELTAFILL18 20MM X 60CM
• 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: 8753059
• Report Number: 3008114965-2019-01073
• Device Sequence Number: 19432585
• Product Code: KRD
• UDI-Device Identifier: 10886704077169
• UDI-Public: 10886704077169
• 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: DLF182060
• Device Lot Number: L14332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• 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.