MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL10 6MM X 16CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF100616
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.The initial reporter phone: (b)(6).[conclusion]: the healthcare professional reported that during the embolization procedure to treat a symptomatic dural cavernous sinus fistula, the 6mm x 16cm deltafill 10 coil (dlf100616 / l13720) was detached before it was used for the procedure, when the package was opened.It was not caused by resistance between the coil and the introducer.Another device was used to complete the procedure.There was no report of any patient adverse event or complication.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (l13720) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined.Assignment of root cause for the event remains speculative and inconclusive, based on the information provided and without the return of the complaint sample.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.This information was not provided in the reported event or available at the time of report submission.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 embolization procedure to treat a symptomatic dural cavernous sinus fistula, the 6mm x 16cm deltafill 10 coil (dlf100616 / l13720) was detached before it was used for the procedure, when the package was opened.It was not caused by resistance between the coil and the introducer.Another device was used to complete the procedure.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 the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the embolization procedure to treat a symptomatic dural cavernous sinus fistula, the 6mm x 16cm deltafill 10 coil (dlf100616 / l13720) was detached before it was used for the procedure, when the package was opened.It was not caused by resistance between the coil and the introducer.Another device was used to complete the procedure.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 6mm x 16cm deltafill 10 coil was received contained in a pouch.Visual inspection was performed.The coil introducer was observed saturated with residues of dried blood, but there was no damage noted.The device underwent a microscopic inspection.The marker band was found at 51cm from the hub.This is within specification.The embolic coil was observed still attached to the resistance heating (rh) coil.No damage was observed on the embolic coil.A review of manufacturing documentation associated with this lot (l13720) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint reported that the 6mm x 16cm deltafill 10 coil became detached before it was used for the procedure.The issue documented in the complaint was not confirmed based on the microscopic observation made on the returned device.The embolic coil was in good condition, still attached to the rh coil.The coil introducer was also found in good condition; residues of dried blood were noted when the introducer was inspected.The residues of dried blood are indicative that flushing may have been inadequate.However, this cannot be conclusively determined.Based on the manufacturing documentation 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 cerenovus product analysis lab on 7/2/2020.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: d10, g4, g7, h2, h3, h6.And h10.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 6MM X 16CM
• 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: 10073235
• Report Number: 3008114965-2020-00160
• Device Sequence Number: 3751983
• Product Code: KRD
• UDI-Device Identifier: 10886704077107
• UDI-Public: 10886704077107
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/28/2020

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: 08/31/2021
• Device Model Number: DLF100616
• Device Catalogue Number: DLF100616
• Device Lot Number: L13720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 07/02/2020; 07/22/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 07/21/2020; 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1