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

Catalog Number	DLF180625
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2019
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: 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).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.The company is seeking this information through the event investigation.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 a healthcare professional, during a coil embolization at the vertebral artery-parent artery occlusion (va-pao), a microcatheter was inserted and delivered to the lesion.A 6mm x 25cm deltafill18 coil (dlf180625, l14325) was used after the coils delta 5mm and versatile fill coils (vfc) were used.A balloon guiding catheter went down while the coil was winded, therefore the complaint coil was re-sheathed.During the re-sheathing, there was a resistance felt when the coil was inserted into a sheath from a y connector.The physician kept re-sheathing it and it was detached.Therefore, it was replaced with another coil and the procedure was completed.The customer states there is no additional information available.
Additional Manufacturer Narrative
(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, during a coil embolization at the vertebral artery parent artery occlusion (va-pao), a microcatheter was inserted and delivered to the lesion.A 6mm x 25cm deltafill18 coil (dlf180625, l14325) was used after the coils delta 5mm and versatile fill coils (vfc) were used.A balloon guiding catheter went down while the coil was winded, therefore the complaint coil was re-sheathed.During the re-sheathing, there was a resistance felt when the coil was inserted into a sheath from a y connector.The physician kept re-sheathing it and it was detached.Therefore, it was replaced with another coil and the procedure was completed.Additional information received indicated that a headway17 terumo microcatheter was used.A non-sterile unit deltafill18 6mm x 25cm was received inside of a pouch.The hub was inspected, and no damages was noted on it.The dpu was inspected and it was found in good normal conditions.Also, the marker band was found at 60 cm from distal end, and it was found within specification.The introducer was inspected, and it was found without damages, however it was found separated from the device.The re-sheating tool was found in good normal conditions.The v-notch was inspected under microscope and it was found in normal good condition.The rh was inspected under microscope and it was found in good normal conditions no heated.The embolic coil was inspected, and it was found detached mechanically from the device without damages.The functional test could not be performed due the conditions in wich the device was returned.Based on the photos provided, it was determined that embolic coil is tangled with the dpu and the introducer.A blue fiber can be observed looped out at the middle of the embolic coil, however no damages were observed in the embolic coil.The rh and articulation joint were observed in good normal conditions; however, the embolic coil was found detached.It appears that the rh was not heated.A manufacturing record evaluation was performed for the finished device l14325 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil - premature detachment¿ was confirmed since during the analysis it was noted that the embolic coil is mechanically detached from the device, the mechanically detach condition from the embolic coil are related with the costumer complaint, however could not be determinate the exactly time when this conditions occur, since the device was used during the procedure.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.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).Updated sections of this report: b5, e1, e2, e3, g4, g7, h2, h10 and concomitant products.Section b5: additional information received indicated that a headway17 terumo microcatheter was used.Section e1: initial reporter phone: (b)(6).A manufacturing record evaluation was performed for the finished device l14325 number, and no non-conformances related to the reported complaint condition were identified.Based on the photos provided, it can be determined that embolic coil is tangled with the dpu and the introducer.A blue fiber can be observed looped out at the middle of the embolic coil, however no damages were observed in the embolic coil.The rh and articulation joint were observed in good normal conditions; however, the embolic coil was found detached.It appears that the rh was not heated.No other damages were observed on the device.The reported condition ¿coil - resistance/friction-with introducer¿ could not be evaluated during a photo analysis.The embolic coil was observed detached and this condition could be related with the complaint reported by the costumer however it cannot be conclusively determined.Further investigation will be performed if the device is received on the laboratory.The reported condition ¿coil - premature detachment¿ cannot be confirmed.The embolic coil was observed detached however the precise time of the detachment cannot be determined.Further investigation will be performed if the device is received on the laboratory.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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: 9214551
• Report Number: 3008114965-2019-01203
• Device Sequence Number: 2483852
• 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,Followup
• Report Date (Section B): 09/27/2019

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: DLF180625
• Device Lot Number: L14325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 10/17/2019; 11/21/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 11/04/2019; 12/10/2019
• 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: DELTA COIL 5MM; HEADWAY17 TERUMO MICROCATHETER; UNKNOWN MICROCATHETER; VERSATILE FILL COILS (VFC)