MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 7MM X 33CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF180733
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.Product code: krd/hcg.Physical manufacturer: (b)(4).Initial reporter: the name of the initial reporter is unknown.The manufacturer representative was provided as the initial reporter name.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
As reported by an affiliate, during a coil embolization of an aneurysm (unknown site), in order to position a deltafill18 coil (dlf180733, s13156) the physician was placing the coil in and out from the aneurysm, but the coil became unraveled when the coil was out.The user managed to complete the embolism with the coil.The procedure was successfully completed without further issues or delay.There was no patient injury or complications reported.The product is not available for the investigation.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.The patient¿s vessel was not torturous and not calcified.The (b)(4) was also used in this procedure.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Addendum (b)(6) 2018): additional information received indicated that there was no resistance at any time during advancement of the coil through the mc.There was no coil entanglement with previously placed coils suspected to contribute to the event.Complaint conclusion: as reported by an affiliate, during a coil embolization of an aneurysm (unknown site), in order to position a deltafill18 coil (dlf180733, s13156) the physician was placing the coil in and out from the aneurysm, but the coil became unraveled when the coil was out.The user managed to complete the embolism with the coil.The procedure was successfully completed without further issues or delay.There was no patient injury or complications reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.The patient¿s vessel was not torturous and not calcified.The dcb2000500 was also used in this procedure.Additional information received indicated that there was no resistance at any time during advancement of the coil through the mc.There was no coil entanglement with previously placed coils suspected to contribute to the event.No further information is available.The deltafill18(dlf180733/ s13156 product was not returned for investigation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.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.

• Brand Name: DELTAFILL18 7MM X 33CM
• 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: 7293285
• Report Number: 3008114965-2018-00538
• Device Sequence Number: 13672374
• Product Code: KRD
• UDI-Device Identifier: 10886704076940
• UDI-Public: 10886704076940
• 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: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: DLF180733
• Device Lot Number: S13156
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1