MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 4MM X 15CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF180415
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2019
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: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.(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 a healthcare professional, pre-sg coil embolization at the right internal iliac artery, a 4mm x 15cm deltafill18 coil (dlf180415, s13278) was used as the third coil but the sheath introducer became damaged.It occurred when the coil was re-sheathed.The complaint coil was replaced with another coil and the procedure completed.The customer states there is no additional information available.One non-sterile unit deltafill18 4mm x 15cm was received inside of a pouch.The hub was inspected, and no damages was noted on it.The dpu was inspected and several kinks it was found.The introducer was inspected, and it was found kinked and with residues of dry blood inside.The re-sheathing tool was inspected, and it was found in good conditions.The v-notch was inspected under microscope and no damages were noted on it.The rh was inspected under microscope and it was found with residues of dry blood but was found no heated.The embolic coil was inspected under microscope and it was found stretched and protruded from the introducer.A manufacturing record evaluation was performed for the finished device s13278 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil introducer - damage¿ was confirm due on the visual analysis the introducer was found kinked.The kinked condition appears 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.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided.However, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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, pre-sg coil embolization at the right internal iliac artery, a 4mm x 15cm deltafill18 coil (dlf180415, s13278) was used as the third coil but the sheath introducer became damaged.It occurred when the coil was re-sheathed.The complaint coil was replaced with another coil and the procedure completed.The customer states there is no additional information available.Based on the analysis of the device received, the embolic coil was found stretched.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section e1.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.

• Brand Name: DELTAFILL18 4MM X 15CM
• 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: 9289592
• Report Number: 3008114965-2019-01231
• Device Sequence Number: 2363008
• Product Code: KRD
• UDI-Device Identifier: 10886704077206
• UDI-Public: 10886704077206
• 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): 10/10/2019

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: 01/31/2020
• Device Catalogue Number: DLF180415
• Device Lot Number: S13278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1