MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL10 2MM X 8CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF100208
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.Procode: krd/hcg.Initial reporter phone: (b)(6).Physical manufacturer 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 as indicated as ¿other¿ as the reason for non-evaluation.If the device returns, a device investigation will be performed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the coil embolization procedure with the target site on the anterior communicating artery (acom), the 2mm x 8cm deltafill 10 coil (dlf100208 / l16127) did not detach in the target site in the patient.The coil was successfully removed from the patient and replaced with another coil; the replacement coil was inserted and implanted without any issue.It was reported that the coil was not stretched when it was removed, it was also still attached to the delivery system.It was reported that a pre-deployment electrical check was not performed.The low battery and fault lights were not seen during the case.The green system ready light did illuminate, and the audible signal beep was heard during the attempt to detach the coil.The same detachment control box and connecting cable were used to detach the replacement coil and complete the procedure.The reported event did not cause any procedural delay.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received by the product analysis lab on 02/10/2020.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the coil embolization procedure with the target site on the anterior communicating artery (acom), the 2mm x 8cm deltafill 10 coil (dlf100208 / l16127) did not detach in the target site in the patient.The coil was successfully removed from the patient and replaced with another coil; the replacement coil was inserted and implanted without any issue.It was reported that the coil was not stretched when it was removed, it was also still attached to the delivery system.It was reported that a pre-deployement electrical check was not performed.The low battery and fault lights were not seen during the case.The green system ready light did illuminate, and the audible signal beep was heard during the attempt to detach the coil.The same detachment control box and connecting cable were used to detach the replacement coil and complete the procedure.The reported event did not cause any procedural delay.There was no report of any patient adverse event or complication.The device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 2mm x 8cm deltafill 10 coil was received contained in a pouch.Visual inspection was performed.No damage was noted on the device.The marker band was found at 43 cm from the distal end; this is within specification.A microscopic inspection was performed.The distal outer sheath did not show evidence of having been softened; an indication that the resistance heating (rh) coil had not been heated and the detachment process had not been initiated.No other damage was noted on the device.Functional analysis: the resistance of the device was measured with multimeter and a lab sample enpower control cable.The initial resistance was measured to be 52.9 o; this is within the specification range of 48.5 o ¿ 56.0 o.The returned device was connected to a lab sample enpower control cable and the unit was connected to detachment control box (dcb).The power was turned on and the system ready light illuminated.A detachment cycle was initiated when the detach button was pressed.The coil detached from the device.A review of manufacturing documentation associated with this lot (l16127) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The reported issue that the 2mm x 8cm deltafill 10 coil did not detach in the target site in the patient during the procedure was not confirmed based on the functional evaluation and analysis performed on the returned device.The device resistance was within specification and when connected to the lab enpower control cable and a lab dcb, the green system ready light illuminated when the power was turned on.The device underwent a detachment cycle and the coil detached without any issue.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: DELTAFILL10 2MM X 8CM
• 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: 9660187
• Report Number: 3008114965-2020-00011
• Device Sequence Number: 19688725
• Product Code: KRD
• UDI-Device Identifier: 10886704077022
• UDI-Public: 10886704077022
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2020

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: 05/31/2022
• Device Model Number: DLF100208
• Device Catalogue Number: DLF100208
• Device Lot Number: L16127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 02/10/2020; 02/10/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 02/10/2020; 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1