MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL10 8MMX20CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF100820
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2019
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).Initial reporter facility name: (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.A review of manufacturing documentation associated with this lot (l12992) 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 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 aneurysm on the right middle cerebral artery, it was reported the 8mm x 20cm deltafill 10 coil (dlf100820 / l12992) was having issue during the attempt that was made to detach the coil.The microcatheter (via®17(microvention-terumo)) and marker were repositioned, and the enpower® dcb 2 (dcb2000500 / lot# unk) and enpower® connecting cable (ccb00015700 / l16026) were exchanged to attempt to detach the coil.After 20 minutes, the coil successfully detached using the original enpower® dcb2 and the enpower connecting cable.It was reported that a pre-deployment electrical check had been performed on the enpower detachment system.The detachment control box battery was full.No fault light was seen during the case, upon pressing the power button, all the lights on the enpower dcb illuminated including the green system ready light.The audible signal beep was heard, and all the connections fit properly without application of excessifve force.There was no report of any patient injury or adverse event.The reported issue did add an additional 20 minutes to the procedure.
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 aneurysm on the right middle cerebral artery, it was reported the 8mm x 20cm deltafill 10 coil (dlf100820 / l12992) was having issue during the attempt that was made to detach the coil.The microcatheter (via®17(microvention-terumo) and marker were repositioned, and the enpower® dcb 2 (dcb2000500 / lot#: unk) and enpower® connecting cable (ccb00015700 / l16026) were exchanged to attempt to detach the coil.After 20 minutes, the coil successfully detached using the original enpower® dcb2 and the enpower connecting cable.It was reported that a pre-deployment electrical check had been performed on the enpower detachment system.The detachment control box battery was full.No fault light was seen during the case, upon pressing the power button, all the lights on the enpower dcb illuminated including the green system ready light.The audible signal beep was heard, and all the connections fit properly without application of excessifve force.There was no report of any patient injury or adverse event.The reported issue did add an additional 20 minutes to the procedure.The product was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 8mm x 20cm deltafill 10 coil and the via®17 microcatheter were returned contained inside a pouch.The 8mm x 20cm deltafill 10 coil underwent visual inspection.The device positioning unit (dpu) was observed several kinked areas.The microscopic inspection was performed.The resistance heating (rh) coil showed evidence that it had been heated.The embolic coil remains implanted and was not available for return.The reported issue documented in the complaint that the coil had issue with detachment could not be confirmed as the coil was not returned.In addition, the rh coil was heated, therefore, the detachment cycle was initiated.The complaint did state that the coil did detach after 20 minutes, using the original enpower detachment control box and the enpower control cable.A review of manufacturing documentation associated with this lot: (l12992) 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.Failure to detach is a known potential product issue associated with the use of the device.The ifu contains several cautions relating to these situations, including instructions for troubleshooting should they be encountered during use.Per the ifu: ¿if a fault light is detected, the system ready light is not illuminated, or there is no detachment after two detachment attempts, replace the dcb unit.If detachment still does not occur, carefully withdraw the entire microcoil system and redeploy a new microcoil system.¿ the physician was able to get the 8mm x 20cm deltafill 10 coil detached using the original enpower dcb2 and the enpower control cable.The device and the concomitant microcatheter was returned, the embolic coil was detached and implanted therefore, was not returned.As a result, the cause of the issue encountered during the attempt to detach the coil could not be conclusively determined.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.
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 12/9/2019.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.

• Brand Name: DELTAFILL10 8MMX20CM
• 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: 9364349
• Report Number: 3008114965-2019-01233
• Device Sequence Number: 19641361
• Product Code: KRD
• UDI-Device Identifier: 10886704079378
• UDI-Public: 10886704079378
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 11/06/2019

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: 05/31/2021
• Device Catalogue Number: DLF100820
• Device Lot Number: L12992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/09/2019; 12/10/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 12/09/2019; 12/11/2019
• 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: CONNECTING CABLE; ENPOWER DCB 2; VIA® 17 MICROCATHETER (MICROVENTION-TERUMO)
• Patient Age: 60 YR